To Evaluate the Optimal Dose of 68Ga-OPS202 as a PET (Pos... | NCT03220217 | Trialant
NCT03220217
Sponsor
Ipsen
Status
Completed
Last Update Posted
Jan 14, 2021Actual
Enrollment
29Actual
Phase
Phase 2
Conditions
Gastro-Enteropancreatic Neuroendocrine Tumor
Interventions
Satoreotide trizoxetan 5-20μg
Satoreotide trizoxetan 30-45μg
Countries
United States
Austria
Denmark
Protocol Section
Identification Module
NCT ID
NCT03220217
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
D-FR-01070-002
Secondary IDs
ID
Type
Description
Link
2016-004928-39
EudraCT Number
Brief Title
To Evaluate the Optimal Dose of 68Ga-OPS202 as a PET (Positron Emission Tomography) Imaging Agent in Subjects With Gastroenteropancreatic Neuroendocrine Tumour (GEP-NET)
Official Title
A Multicentre, Randomised, Dose-confirmation, Factorial Phase II Study to Evaluate the Optimal Dose of 68Ga-OPS202 as a PET Imaging Agent in Subjects With Gastroenteropancreatic Neuroendocrine Tumour (GEP-NET)
Acronym
Not provided
Organization
IpsenINDUSTRY
Status Module
Record Verification Date
Jan 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 26, 2017Actual
Primary Completion Date
Jul 25, 2019Actual
Completion Date
Aug 5, 2019Actual
First Submitted Date
Jun 26, 2017
First Submission Date that Met QC Criteria
Jul 13, 2017
First Posted Date
Jul 18, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Oct 8, 2020
Results First Submitted that Met QC Criteria
Jan 8, 2021
Results First Posted Date
Jan 14, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jan 23, 2020
Certification/Extension First Submitted that Passed QC Review
Jan 8, 2021
Certification/Extension First Posted Date
Jan 14, 2021Actual
Last Update Submitted Date
Jan 8, 2021
Last Update Posted Date
Jan 14, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
IpsenINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this clinical research is to confirm the optimal dose of 68Ga-satoreotide trizoxetan (68Ga-IPN01070), formerly 68Ga-OPS202, as a PET imaging agent to be used to detect and localize gastro-entero-pancreatic neuroendocrine tumors (GEP-NETs). 68Ga-IPN01070 is a radiolabelled imaging agent to be used in association with Positron-Emission-Tomography (PET). 68Ga-IPN01070 is made of two main components: 1) IPN01070, an antagonistic somatostatin analogue which binds to the somatostatin receptor (type 2) present on the surface of the tumor cells and 2) Gallium-68, a radioisotope that combined with IPN01070 can be seen in the PET scanner.
Detailed Description
Not provided
Conditions Module
Conditions
Gastro-Enteropancreatic Neuroendocrine Tumor
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
29Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
5-20μg/40-80 MBq, 30-45μg/100-140 MBq
Experimental
Subjects will receive a first intravenous (i.v.) injection of satoreotide trizoxetan with a peptide mass dose range of 5 to 20 μg and a radioactivity dose range 40 to 80 MBq. After 15 to 21 days the subjects will receive a second i.v. injection of satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range 100 to 140 MBq.
Drug: Satoreotide trizoxetan 5-20μg
Drug: Satoreotide trizoxetan 30-45μg
5-20μg/100-140 MBq, 30-45μg/160-200 MBq
Experimental
Subjects will receive a first i.v. injection of satoreotide trizoxetan with a peptide mass dose range of 5 to 20 μg and a radioactivity dose range 100 to 140 MBq. After 15 to 21 days the subjects will receive a second i.v. injection of satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range 160 to 200 MBq.
Drug: Satoreotide trizoxetan 5-20μg
Drug: Satoreotide trizoxetan 30-45μg
5-20μg/160-200 MBq, 30-45μg/40-80 MBq
Experimental
Subjects will receive a first i.v. injection of satoreotide trizoxetan with a peptide mass dose range of 5 to 20 μg and a radioactivity dose range 160 to 200 MBq. After 15 to 21 days the subjects will receive a second i.v. injection of satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range 40 to 80 MBq.
Drug: Satoreotide trizoxetan 5-20μg
Drug: Satoreotide trizoxetan 30-45μg
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Satoreotide trizoxetan 5-20μg
Drug
Positron emission tomography (PET) imaging agent
5-20μg/100-140 MBq, 30-45μg/160-200 MBq
5-20μg/160-200 MBq, 30-45μg/40-80 MBq
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Relative Lesion Counts Presented by Combination of Injected Peptide/Radioactivity Dose Ranges
For each combination of injected peptide/radioactivity dose range, relative lesion counts were measured as the ratio of the number of lesions detected by 68Ga-satoreotide trizoxetan PET/CT and PET readings to the number of lesions assessed by standard-of-truth (SoT). The SoT in this study was the contrast enhanced (ce)CT scan images acquired at Visit 2 (Day 1) and Visit 3 (Days 16 to 22). Relative lesion counts for PET/CT and PET readings are presented for all organs, primary site of GEP-NET and per organ by each combination of injected peptide/radioactivity dose range after the 1st and 2nd injections.
Day 1 and Days 16 to 22
Relative Lesion Counts Presented by Peptide Mass and Radioactivity Dose Ranges
For each combination of injected peptide/radioactivity dose range, relative lesion counts were measured as the ratio of the number of lesions detected by 68Ga-satoreotide trizoxetan PET/CT and PET readings to the number of lesions assessed by SoT. The SoT in this study was the ceCT scan images acquired at Visit 2 (Day 1) and Visit 3 (Day 16 to 22). Relative lesion counts for PET/CT and PET readings are presented for all organs, primary site of GEP-NET and per organ by both peptide mass range and radioactivity dose range.
Day 1 and Days 16 to 22
Secondary Outcomes
Measure
Description
Time Frame
Image Quality as Assessed by Tumour-To-Background Ratio Presented by Combination of Injected Peptide/Radioactivity Dose Range
For each PET assessment, image quality was quantitatively measured by the tumour-to-background ratio, obtained using the mean of all lesions tumour-to-backgrounds, for each of the following organs; liver, lymph nodes, bone and lungs. The tumour-to-background ratio was computed by mean standardised uptake value (SUVmean) of the lesion divided by the SUVmean of the subject's reference tissue (tumour-free liver or aortic blood). A high tumour-to-background ratio indicates high effectiveness of 68Ga-satoreotide trizoxetan as a diagnostic agent. Tumour-to-background ratios are presented for primary site of GEP-NET and per organ by each combination of injected peptide/radioactivity dose range.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Pathologically confirmed, well differentiated functioning or non-functioning metastatic GEP-NET (Grade I and II as per World Health Organisation classification 2010)
Confirmed presence of somatostatin receptors (type 2) on technically evaluable tumour lesions documented by a positive Somatostatin Receptor Scan acquired within 6 months prior to screening (Visit 1) and showing minimally two lesions in at least one of the key organs; these images shall be available to be sent to the imaging core lab electronically to ascertain quality and admissibility
Body weight between 50 kg (110 lb) and 110 kg (243 lb), inclusive
Adequate bone marrow, liver and renal function
Eastern Cooperative Oncology Group (ECOG) performance status ≤2
Exclusion Criteria:
Fewer than five lesions in total and more than 25 lesions/organ detected by the previous somatostatin receptor scan in key organs: liver, lymph nodes, bone or lungs
Subject who have received treatment of any somatostatin analogue, including Somatuline® Autogel® /Depot®, Sandostatin® LAR within 28 days, and Sandostatin® within 24 hours prior to first 68Ga-OPS202 administration
Prior or planned administration of a radiopharmaceutical within 8 half-lives of the radionuclide
Any condition that precludes the proper performance of PET and/or CT scan: a) Subjects who are not able to tolerate the CT contrast agent, b) Subjects with metal implants or arthroplasty, or any other objects that might interfere with the PET and/or CT analysis, c) Subjects unable to raise arms for prolonged imaging purposes, d) Subjects unable to lie still for the entire imaging time, e) Subjects weighing greater than 110 kg (243 lb)
Miller CG, Gronbaek H, Virgolini I, Kjaer A, Terve P, Bahri S, Iversen P, Svirydenka H, Rohban T, McEwan S. A novel read methodology to evaluate the optimal dose of 68Ga-satoreotide trizoxetan as a PET imaging agent in patients with gastroenteropancreatic neuroendocrine tumours: a phase II clinical trial. EJNMMI Res. 2021 Sep 6;11(1):84. doi: 10.1186/s13550-021-00819-1.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
The Screening Visit (Visit 1) was performed within 2 weeks prior to the first 68Ga-satoreotide trizoxetan administration. Subjects' eligibility was re-checked by the investigator at Visit 2 (Day 1) before randomisation to 1 of 3 study arms (A, B or C) with differing 68Ga-satoreotide trizoxetan peptide mass dose and radioactivity dose range combinations.
Recruitment Details
This dose-confirmation study was conducted at 4 centres between September 2017 and August 2019. Adult subjects with somatostatin receptor subtype 2 (sstr2)-positive gastroenteropancreatic neuroendocrine tumour (GEP-NET) were randomised to investigational imaging product with Gallium-68 (68Ga)-satoreotide trizoxetan (68Ga-IPN01070, formerly known as 68Ga-OPS202).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Arm A: 5-20 µg/40-80 MBq Then 30-45 µg/100-140 MBq
Subjects received a single intravenous (i.v.) injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 micrograms (μg) and a radioactivity dose range of 40-80 Megabecquerel (MBq) on Visit 2 (Day 1).
After 15 to 21 days at Visit 3 (Days 16 to 22), subjects received a second i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range of 100-140 MBq.
Both injections were followed by positron emission tomography(PET)/computed tomography (CT) scan imaging 1 hour post dosing (up to 80 min).
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Received 68Ga-satoreotide trizoxetan
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
May 20, 2019
Sep 7, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Netherlands
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Factorial Assignment
Intervention Model Description
Not provided
Primary Purpose
Diagnostic
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Single
Masking Description
All the primary and secondary imaging endpoints are read by third-party independent readers. Most of the reading will be conducted in blinded manner.
Who Masked
Outcomes Assessor
5-20μg/40-80 MBq, 30-45μg/100-140 MBq
68Ga-OPS202 5-20μg, 68Ga-IPN01070 5-20μg
Satoreotide trizoxetan 30-45μg
Drug
Positron emission tomography (PET) imaging agent
5-20μg/100-140 MBq, 30-45μg/160-200 MBq
5-20μg/160-200 MBq, 30-45μg/40-80 MBq
5-20μg/40-80 MBq, 30-45μg/100-140 MBq
68Ga-OPS202 30-45μg, 68Ga-IPN01070 30-45μg
Day 1 and Days 16 to 22
Image Quality as Assessed by Tumour-To-Background Ratio Presented by Peptide Mass and Radioactivity Dose Ranges
For each PET assessment image quality was quantitatively measured by the tumour-to-background ratio, obtained using the mean of all lesions tumour-to-backgrounds, for each of the following organs; liver, lymph nodes, bone and lungs. The tumour-to-background ratio was computed by SUVmean of the lesion divided by the SUVmean of the subject's reference tissue (tumour-free liver or aortic blood). A high tumour-to-background ratio indicates high effectiveness of 68Ga-satoreotide trizoxetan as a diagnostic agent. Tumour-to-background ratios are presented for primary site of GEP-NET and per organ by both peptide mass range and radioactivity dose range.
Day 1 and Days 16 to 22
Image Quality as Assessed by Independent Blinded Readers Quality Score
A qualitative analysis of the image was assessed by 2 independent blinded readers using a quality score (performed as a back-up to the quantitative quality measured by tumour-to-background analysis). For each PET/CT and PET assessment, each reader performed a direct comparison of the 2 scans from Visit 2 and Visit 3. They noted which scan provided superior images based on overall image quality and lesion count and attributed a score for each assessment. The score for the assessment having superior images was set to "1", and score for the assessment not selected was set to "0". In case of equal quality, both assessments had a score of "1". The image quality score for PET/CT and PET readings as cumulative sum of readers' scores across all subjects by peptide mass and radioactivity dose range combination is presented. Score ranges from 0-16 with higher score indicating more assessments classed as superior.
Day 1 and Days 16 to 22
Lesion Maximum Standardised Uptake Value (SUVmax) Presented by Combination of Injected Peptide/Radioactivity Dose Ranges
For each PET assessment, SUVmax was measured for each lesion, up to a maximum of 5 most avid lesions per organ that were confirmed by SoT assessment. In order to obtain a unique measure per organ, values of the SUVmax were computed within each of the following organs; liver, lymph nodes, bone and lungs. SUVmax results are presented for primary site of GEP-NET and per organ by each combination of injected peptide/radioactivity dose range.
Day 1 and Days 16 to 22
Lesion SUVmax Presented by Peptide Mass and Radioactivity Dose Ranges
For each PET assessment, SUVmax was measured for each lesion, up to a maximum of 5 most avid lesions per organ that are confirmed by SoT assessment. In order to obtain a unique measure per organ, mean of the SUVmax was computed within each of the liver, lymph nodes, bone and lungs. SUVmax results are presented for primary site of GEP-NET and per organ by both peptide mass range and radioactivity dose range.
Day 1 and Days 16 to 22
Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Combination of Injected Peptide/Radioactivity Dose Range
For each PET/CT and PET assessment, the absolute number of lesions detected by 68Ga-satoreotide trizoxetan were reported for each of the following anatomic sites; primary site of GEP-NET, liver, lymph nodes, axial/appendicular skeleton (bone) and lungs. The absolute number of lesions for PET/CT and PET readings for the 5 anatomic sites are presented by each combination of injected peptide/radioactivity dose range.
Day 1 and Days 16 to 22
Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Peptide Mass and Radioactivity Dose Ranges
For each PET/CT and PET assessment, the absolute number of lesions detected by 68Ga-satoreotide trizoxetan were reported for each of the following anatomic sites; primary site of GEP-NET, lymph nodes, liver, axial/appendicular skeleton (bone) and lungs. The absolute number of lesions for PET/CT and PET readings for the 5 anatomic sites are presented by both peptide mass range and radioactivity dose range.
Day 1 and Days 16 to 22
Difference in Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Compared to Lesions Detected by SoT Presented by Combination of Injected Peptide/Radioactivity Dose Range
For each PET/CT and PET assessment, the number of lesions detected by 68Ga-satoreotide trizoxetan and SoT (ceCT) were reported for each of the following anatomic sites; primary site of GEP-NET, lymph nodes, liver, axial/appendicular skeleton (bone) and lungs. The difference was calculated by number of lesions detected by 68Ga-satoreotide trizoxetan - number of lesions detected by ceCT scan. A positive difference indicates that more lesions were detected by 68Ga-satoreotide trizoxetan than by ceCT scan. A negative difference indicates that more lesions were detected by ceCT scan than by 68Ga-satoreotide trizoxetan. The difference in number of lesions for PET/CT and PET readings for the 5 anatomic sites are presented by each combination of injected peptide/radioactivity dose range.
Day 1 and Days 16 to 22
Difference in Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Compared to Lesions Detected by SoT Presented by Peptide Mass and Radioactivity Dose Ranges
For each PET/CT and PET assessment, the number of lesions detected by 68Ga-satoreotide trizoxetan and SoT (ceCT) were reported for each of the following anatomic sites; primary site of GEP-NET, lymph nodes, liver, axial/appendicular skeleton (bone) and lungs. The difference was calculated by number of lesions detected by 68Ga-satoreotide trizoxetan - number of lesions detected by ceCT scan. A positive difference indicates that more lesions were detected by 68Ga-satoreotide trizoxetan than by ceCT scan. A negative difference indicates that more lesions were detected by ceCT scan than by 68Ga-satoreotide trizoxetan. The difference in number of lesions for PET/CT and PET readings for the 5 anatomic sites results are presented by both peptide mass range and radioactivity dose range.
Day 1 and Days 16 to 22
Innsbruck
A-6020
Austria
University Clinic for Radiology and Nuclear Medicine
Vienna
A-1090
Austria
Aarhus University Hospital
Aarhus
DK-8000
Denmark
Rigshospitalet, University of Copenhagen
Copenhagen
DK-2100
Denmark
FG001
Arm B: 5-20 µg/100-140 MBq Then 30-45 µg/160-200 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity dose range of 100-140 MBq on Visit 2 (Day 1).
After 15 to 21 days at Visit 3 (Days 16 to 22), subjects received a second i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range of 160-200 MBq.
Both injections were followed by PET/CT scan imaging 1 hour post dosing (up to 80 min).
FG002
Arm C: 5-20 µg/160-200 MBq Then 30-45 µg/40-80 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity dose range of 160-200 MBq on Visit 2 (Day 1).
After 15 to 21 days at Visit 3 (Days 16 to 22), subjects received a second i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 40-80 MBq.
Both injections were followed by PET/CT scan imaging 1 hour post dosing (up to 80 min).
FG0008 subjects
FG00110 subjects
FG00211 subjects
COMPLETED
Completed Study
FG0008 subjects
FG0019 subjects
FG00210 subjects
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0021 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
Subject Missed Procedure
FG0000 subjects
FG0010 subjects
FG0021 subjects
The randomised population included all subjects randomly assigned to a dosing arm/sequence.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Arm A: 5-20 µg/40-80 MBq Then 30-45 µg/100-140 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity dose range of 40-80 MBq on Visit 2 (Day 1).
After 15 to 21 days at Visit 3 (Days 16 to 22), subjects received a second i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range of 100-140 MBq.
Both injections were followed by PET/CT scan imaging 1 hour post dosing (up to 80 min).
BG001
Arm B: 5-20 µg/100-140 MBq Then 30-45 µg/160-200 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity dose range of 100-140 MBq on Visit 2 (Day 1).
After 15 to 21 days at Visit 3 (Days 16 to 22), subjects received a second i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range of 160-200 MBq.
Both injections were followed by PET/CT scan imaging 1 hour post dosing (up to 80 min).
BG002
Arm C: 5-20 µg/160-200 MBq Then 30-45 µg/40-80 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity dose range of 160-200 MBq on Visit 2 (Day 1).
After 15 to 21 days at Visit 3 (Days 16 to 22), subjects received a second i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 40-80 MBq.
Both injections were followed by PET/CT scan imaging 1 hour post dosing (up to 80 min).
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0008
BG00110
BG00211
BG00329
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00070.5± 11.1
BG00167.6± 6.4
BG002
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0016
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Relative Lesion Counts Presented by Combination of Injected Peptide/Radioactivity Dose Ranges
For each combination of injected peptide/radioactivity dose range, relative lesion counts were measured as the ratio of the number of lesions detected by 68Ga-satoreotide trizoxetan PET/CT and PET readings to the number of lesions assessed by standard-of-truth (SoT). The SoT in this study was the contrast enhanced (ce)CT scan images acquired at Visit 2 (Day 1) and Visit 3 (Days 16 to 22). Relative lesion counts for PET/CT and PET readings are presented for all organs, primary site of GEP-NET and per organ by each combination of injected peptide/radioactivity dose range after the 1st and 2nd injections.
Results are presented for the Per Protocol (PP) population which consisted of the first 24 randomised subjects who could be assessed and for whom no major protocol violations/deviations impacting primary endpoint results occurred. Only subjects with data available were included in the analysis.
Posted
Median
Full Range
Ratio
Day 1 and Days 16 to 22
ID
Title
Description
OG000
Arm A: 5-20 μg/40-80 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 40-80 MBq on Visit 2/Day 1.
OG001
Arm A: 30-45 μg/100-140 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 100-140 MBq on Visit 3/Days 16 to 22.
OG002
Arm B: 5-20 μg/100-140 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 100-140 MBq on Visit 2/Day 1.
OG003
Arm B: 30-45 μg/160-200 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 160-200 MBq on Visit 3/Days 16 to 22.
OG004
Arm C: 5-20 μg/160-200 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 160-200 MBq on Visit 2/Day 1.
OG005
Arm C: 30-45 μg/40-80 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 40-80 MBq on Visit 3/Days 16 to 22.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG003
Title
Denominators
Categories
PET/CT: All Organs
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG003
Primary
Relative Lesion Counts Presented by Peptide Mass and Radioactivity Dose Ranges
For each combination of injected peptide/radioactivity dose range, relative lesion counts were measured as the ratio of the number of lesions detected by 68Ga-satoreotide trizoxetan PET/CT and PET readings to the number of lesions assessed by SoT. The SoT in this study was the ceCT scan images acquired at Visit 2 (Day 1) and Visit 3 (Day 16 to 22). Relative lesion counts for PET/CT and PET readings are presented for all organs, primary site of GEP-NET and per organ by both peptide mass range and radioactivity dose range.
Results are presented for the PP population which consisted of the first 24 randomised subjects who could be assessed and for whom no major protocol violations/deviations impacting primary endpoint results occurred. Only subjects with data available were included in the analysis.
Posted
Median
Full Range
Ratio
Day 1 and Days 16 to 22
ID
Title
Description
OG000
Peptide Mass Dose Range 5-20 μg
Subjects from Arms A, B and C who received an injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg on Visit 2 (Day 1).
OG001
Peptide Mass Dose Range 30-45 μg
Subjects from Arms A, B and C who received an injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg on Visit 3 (Days 16-22).
OG002
Secondary
Image Quality as Assessed by Tumour-To-Background Ratio Presented by Combination of Injected Peptide/Radioactivity Dose Range
For each PET assessment, image quality was quantitatively measured by the tumour-to-background ratio, obtained using the mean of all lesions tumour-to-backgrounds, for each of the following organs; liver, lymph nodes, bone and lungs. The tumour-to-background ratio was computed by mean standardised uptake value (SUVmean) of the lesion divided by the SUVmean of the subject's reference tissue (tumour-free liver or aortic blood). A high tumour-to-background ratio indicates high effectiveness of 68Ga-satoreotide trizoxetan as a diagnostic agent. Tumour-to-background ratios are presented for primary site of GEP-NET and per organ by each combination of injected peptide/radioactivity dose range.
Results are presented for the PP population which consisted of the first 24 randomised subjects who could be assessed and for whom no major protocol violations/deviations impacting primary endpoint results occurred. Only subjects with data available were included in the analysis.
Posted
Median
Full Range
Ratio
Day 1 and Days 16 to 22
ID
Title
Description
OG000
Arm A: 5-20 μg/40-80 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 40-80 MBq on Visit 2 (Day 1).
OG001
Arm A: 30-45 μg/100-140 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 100-140 MBq on Visit 3 (Days 16 to 22).
Secondary
Image Quality as Assessed by Tumour-To-Background Ratio Presented by Peptide Mass and Radioactivity Dose Ranges
For each PET assessment image quality was quantitatively measured by the tumour-to-background ratio, obtained using the mean of all lesions tumour-to-backgrounds, for each of the following organs; liver, lymph nodes, bone and lungs. The tumour-to-background ratio was computed by SUVmean of the lesion divided by the SUVmean of the subject's reference tissue (tumour-free liver or aortic blood). A high tumour-to-background ratio indicates high effectiveness of 68Ga-satoreotide trizoxetan as a diagnostic agent. Tumour-to-background ratios are presented for primary site of GEP-NET and per organ by both peptide mass range and radioactivity dose range.
Results are presented for the PP population which consisted of the first 24 randomised subjects who could be assessed and for whom no major protocol violations/deviations impacting primary endpoint results occurred. Only subjects with data available were included in the analysis.
Posted
Median
Full Range
Ratio
Day 1 and Days 16 to 22
ID
Title
Description
OG000
Peptide Mass Dose Range 5-20 μg
Subjects from Arms A, B and C who received an injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg on Visit 2 (Day 1).
OG001
Peptide Mass Dose Range 30-45 μg
Subjects from Arms A, B and C who received an injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg on Visit 3 (Days 16-22).
Secondary
Image Quality as Assessed by Independent Blinded Readers Quality Score
A qualitative analysis of the image was assessed by 2 independent blinded readers using a quality score (performed as a back-up to the quantitative quality measured by tumour-to-background analysis). For each PET/CT and PET assessment, each reader performed a direct comparison of the 2 scans from Visit 2 and Visit 3. They noted which scan provided superior images based on overall image quality and lesion count and attributed a score for each assessment. The score for the assessment having superior images was set to "1", and score for the assessment not selected was set to "0". In case of equal quality, both assessments had a score of "1". The image quality score for PET/CT and PET readings as cumulative sum of readers' scores across all subjects by peptide mass and radioactivity dose range combination is presented. Score ranges from 0-16 with higher score indicating more assessments classed as superior.
Results are presented for the PP population which consisted of the first 24 randomised subjects who could be assessed and for whom no major protocol violations/deviations impacting primary endpoint results occurred. Only subjects with data available were included in the analysis. Note: image scores are presented as the cumulative sum of both readers' results across all subjects analysed per specified combination/visit; they do not represent summarised values.
Posted
Number
Cumulative Sum of Readers' Scores
Day 1 and Days 16 to 22
ID
Title
Description
OG000
Radioactivity Dose Range 40-80 MBq
Subjects from Arms A and C who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose of 40-80 MBq on either Visit 2 (Day 1) or on Visit 3 (Days 16-22).
Secondary
Lesion Maximum Standardised Uptake Value (SUVmax) Presented by Combination of Injected Peptide/Radioactivity Dose Ranges
For each PET assessment, SUVmax was measured for each lesion, up to a maximum of 5 most avid lesions per organ that were confirmed by SoT assessment. In order to obtain a unique measure per organ, values of the SUVmax were computed within each of the following organs; liver, lymph nodes, bone and lungs. SUVmax results are presented for primary site of GEP-NET and per organ by each combination of injected peptide/radioactivity dose range.
Results are presented for the PP population which consisted of the first 24 randomised subjects who could be assessed and for whom no major protocol violations/deviations impacting primary endpoint results occurred. Only subjects with data available were included in the analysis.
Posted
Median
Full Range
SUV
Day 1 and Days 16 to 22
ID
Title
Description
OG000
Arm A: 5-20 μg/40-80 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 40-80 MBq on Visit 2 (Day 1).
OG001
Arm A: 30-45 μg/100-140 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 100-140 MBq on Visit 3 (Days 16 to 22).
OG002
Secondary
Lesion SUVmax Presented by Peptide Mass and Radioactivity Dose Ranges
For each PET assessment, SUVmax was measured for each lesion, up to a maximum of 5 most avid lesions per organ that are confirmed by SoT assessment. In order to obtain a unique measure per organ, mean of the SUVmax was computed within each of the liver, lymph nodes, bone and lungs. SUVmax results are presented for primary site of GEP-NET and per organ by both peptide mass range and radioactivity dose range.
Results are presented for the PP population which consisted of the first 24 randomised subjects who could be assessed and for whom no major protocol violations/deviations impacting primary endpoint results occurred. Only subjects with data available were included in the analysis.
Posted
Median
Full Range
SUV
Day 1 and Days 16 to 22
ID
Title
Description
OG000
Peptide Mass Dose Range 5-20 μg
Subjects from Arms A, B and C who received an injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg on Visit 2 (Day 1).
OG001
Peptide Mass Dose Range 30-45 μg
Subjects from Arms A, B and C who received an injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg on Visit 3 (Days 16-22).
OG002
Radioactivity Dose Range 40-80 MBq
Secondary
Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Combination of Injected Peptide/Radioactivity Dose Range
For each PET/CT and PET assessment, the absolute number of lesions detected by 68Ga-satoreotide trizoxetan were reported for each of the following anatomic sites; primary site of GEP-NET, liver, lymph nodes, axial/appendicular skeleton (bone) and lungs. The absolute number of lesions for PET/CT and PET readings for the 5 anatomic sites are presented by each combination of injected peptide/radioactivity dose range.
Results are presented for the PP population which consisted of the first 24 randomised subjects who could be assessed and for whom no major protocol violations/deviations impacting primary endpoint results occurred. Only subjects with data available were included in the analysis.
Posted
Median
Full Range
Lesions
Day 1 and Days 16 to 22
ID
Title
Description
OG000
Arm A: 5-20 μg/40-80 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 40-80 MBq on Visit 2 (Day 1).
OG001
Arm A: 30-45 μg/100-140 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 100-140 MBq on Visit 3 (Days 16 to 22).
OG002
Secondary
Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Peptide Mass and Radioactivity Dose Ranges
For each PET/CT and PET assessment, the absolute number of lesions detected by 68Ga-satoreotide trizoxetan were reported for each of the following anatomic sites; primary site of GEP-NET, lymph nodes, liver, axial/appendicular skeleton (bone) and lungs. The absolute number of lesions for PET/CT and PET readings for the 5 anatomic sites are presented by both peptide mass range and radioactivity dose range.
Results are presented for the PP population which consisted of the first 24 randomised subjects who could be assessed and for whom no major protocol violations/deviations impacting primary endpoint results occurred. Only subjects with data available were included in the analysis.
Posted
Median
Full Range
Lesions
Day 1 and Days 16 to 22
ID
Title
Description
OG000
Peptide Mass Dose Range 5-20 μg
Subjects from Arms A, B and C who received an injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg on Visit 2 (Day 1).
OG001
Peptide Mass Dose Range 30-45 μg
Subjects from Arms A, B and C who received an injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg on Visit 3 (Days 16-22).
OG002
Radioactivity Dose Range 40-80 MBq
Secondary
Difference in Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Compared to Lesions Detected by SoT Presented by Combination of Injected Peptide/Radioactivity Dose Range
For each PET/CT and PET assessment, the number of lesions detected by 68Ga-satoreotide trizoxetan and SoT (ceCT) were reported for each of the following anatomic sites; primary site of GEP-NET, lymph nodes, liver, axial/appendicular skeleton (bone) and lungs. The difference was calculated by number of lesions detected by 68Ga-satoreotide trizoxetan - number of lesions detected by ceCT scan. A positive difference indicates that more lesions were detected by 68Ga-satoreotide trizoxetan than by ceCT scan. A negative difference indicates that more lesions were detected by ceCT scan than by 68Ga-satoreotide trizoxetan. The difference in number of lesions for PET/CT and PET readings for the 5 anatomic sites are presented by each combination of injected peptide/radioactivity dose range.
Results are presented for the PP population which consisted of the first 24 randomised subjects who could be assessed and for whom no major protocol violations/deviations impacting primary endpoint results occurred. Only subjects with data available were included in the analysis.
Posted
Median
Full Range
Lesions
Day 1 and Days 16 to 22
ID
Title
Description
OG000
Arm A: 5-20 μg/40-80 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 40-80 MBq on Visit 2 (Day 1).
OG001
Arm A: 30-45 μg/100-140 MBq
Secondary
Difference in Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Compared to Lesions Detected by SoT Presented by Peptide Mass and Radioactivity Dose Ranges
For each PET/CT and PET assessment, the number of lesions detected by 68Ga-satoreotide trizoxetan and SoT (ceCT) were reported for each of the following anatomic sites; primary site of GEP-NET, lymph nodes, liver, axial/appendicular skeleton (bone) and lungs. The difference was calculated by number of lesions detected by 68Ga-satoreotide trizoxetan - number of lesions detected by ceCT scan. A positive difference indicates that more lesions were detected by 68Ga-satoreotide trizoxetan than by ceCT scan. A negative difference indicates that more lesions were detected by ceCT scan than by 68Ga-satoreotide trizoxetan. The difference in number of lesions for PET/CT and PET readings for the 5 anatomic sites results are presented by both peptide mass range and radioactivity dose range.
Results are presented for the PP population which consisted of the first 24 randomised subjects who could be assessed and for whom no major protocol violations/deviations impacting primary endpoint results occurred. Only subjects with data available were included in the analysis.
Posted
Median
Full Range
Lesions
Day 1 and Days 16 to 22
ID
Title
Description
OG000
Peptide Mass Dose Range 5-20 μg
Subjects from Arms A, B and C who received an injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg on Visit 2 (Day 1).
OG001
Peptide Mass Dose Range 30-45 μg
Time Frame
Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
Description
All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Arm A: 5-20 μg/40-80 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 40-80 MBq on Visit 2 (Day 1).
0
8
0
8
2
8
EG001
Arm A: 30-45 μg/100-140 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 100-140 MBq on Visit 3 (Days 16 to 22).
0
8
0
8
4
8
EG002
Arm B: 5-20 μg/100-140 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 100-140 MBq on Visit 2 (Day 1).
0
9
0
9
4
9
EG003
Arm B: 30-45 μg/160-200 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 160-200 MBq on Visit 3 (Days 16 to 22).
0
9
0
9
6
9
EG004
Arm C: 5-20 μg/160-200 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 160-200 MBq.
0
10
0
10
3
10
EG005
Arm C: 30-45 μg/40-80 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 40-80 MBq on Visit 3 (Days 16 to 22).
0
10
0
10
5
10
EG006
Overall
Total number of AEs experienced across all Arms.
0
27
0
27
18
27
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected9 at risk
EG0032 events2 affected9 at risk
EG0040 events0 affected10 at risk
EG0051 events1 affected10 at risk
EG0064 events4 affected27 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Administration site pain
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Feeling cold
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Fatigue
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Injection site pain
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected8 at risk
EG0012 events2 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Blood potassium increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Blood urine present
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Flushing
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Basedow's disease
Endocrine disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
In each injected peptide/radioactivity dose combination for outcome measures 1, 3 and 6, the number of subjects with lesions in the primary site of GEP-NET, bone and lung was too small (0 to 3) to allow for a meaningful interpretation of the results. Similarly, in each category of peptide mass range and radioactivity dose range for outcome measures 2, 4 and 7, the number of subjects with lesions in bone and lung was too small (0 to 2) to allow for a meaningful interpretation of the results.
Subjects from Arms A and C who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose of 40-80 MBq on either Visit 2 (Day 1) or on Visit 3 (Days 16-22).
OG003
Radioactivity Dose Range 100-140 MBq
Subjects from Arms A and B who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose range of 100-140 MBq on either Visit 2(Day 1) or on Visit 3 (Days 16-22).
OG004
Radioactivity Dose Range 160-200 MBq
Subjects from Arms B and C who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose range of 160-200 MBq on either Visit 2 (Day 1) or on Visit 3 (Days 16-22).
Units
Counts
Participants
OG00024
OG00124
OG00216
OG00316
OG00416
Title
Denominators
Categories
PET/CT: All Organs
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00216
ParticipantsOG00316
ParticipantsOG00416
Title
Measurements
OG0002.7(0.64 to 16.25)
OG0012.7(0.82 to 13.50)
OG0023.1(0.73 to 15.00)
OG003
PET/CT: Primary Site
ParticipantsOG0005
ParticipantsOG0015
ParticipantsOG0023
ParticipantsOG0034
PET/CT: Liver
ParticipantsOG00017
ParticipantsOG00117
ParticipantsOG00213
ParticipantsOG0039
PET/CT: Lymph Nodes
ParticipantsOG00013
ParticipantsOG00113
ParticipantsOG0027
ParticipantsOG0039
PET/CT: Bone
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0031
PET/CT: Lung
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0032
PET: All Organs
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00216
ParticipantsOG00316
PET: Primary Site
ParticipantsOG0005
ParticipantsOG0015
ParticipantsOG0023
ParticipantsOG0034
PET: Liver
ParticipantsOG00017
ParticipantsOG00117
ParticipantsOG00213
ParticipantsOG0039
PET: Lymph Nodes
ParticipantsOG00013
ParticipantsOG00113
ParticipantsOG0027
ParticipantsOG0039
PET: Bone
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0031
PET: Lung
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0032
OG002
Arm B: 5-20 μg/100-140 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 100-140 MBq on Visit 2 (Day 1).
OG003
Arm B: 30-45 μg/160-200 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 160-200 MBq on Visit 3 (Days 16 to 22).
OG004
Arm C: 5-20 μg/160-200 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 160-200 MBq.
OG005
Arm C: 30-45 μg/40-80 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 40-80 MBq on Visit 3 (Days 16 to 22).
Units
Counts
Participants
OG0008
OG0018
OG0028
OG0038
OG0048
OG0058
Title
Denominators
Categories
Primary Site
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0032
ParticipantsOG0041
ParticipantsOG0051
Title
Measurements
OG00026.4(7.04 to 45.84)
OG00117.5(7.07 to 27.87)
OG0024.8(4.57 to 33.81)
OG003
Liver
ParticipantsOG0005
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG0035
Lymph Nodes
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0026
ParticipantsOG0036
Bone
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
Lung
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
Radioactivity Dose Range 40-80 MBq
Subjects from Arms A and C who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose of 40-80 MBq on either Visit 2 (Day 1) or on Visit 3 (Days 16-22).
OG003
Radioactivity Dose Range 100-140 MBq
Subjects from Arms A and B who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose range of 100-140 MBq on either Visit 2(Day 1) or on Visit 3 (Days 16-22).
OG004
Radioactivity Dose Range 160-200 MBq
Subjects from Arms B and C who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose range of 160-200 MBq on either Visit 2 (Day 1) or on Visit 3 (Days 16-22).
Units
Counts
Participants
OG00024
OG00124
OG00216
OG00316
OG00416
Title
Denominators
Categories
Primary Site
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0023
ParticipantsOG0035
ParticipantsOG0043
Title
Measurements
OG0005.9(2.28 to 45.84)
OG0017.1(2.22 to 32.81)
OG0027.0(2.22 to 45.84)
OG003
Liver
ParticipantsOG00018
ParticipantsOG00118
ParticipantsOG00213
ParticipantsOG00310
Lymph Nodes
ParticipantsOG00014
ParticipantsOG00114
ParticipantsOG0028
ParticipantsOG0039
Bone
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0031
Lung
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG001
Radioactivity Dose Range 100-140 MBq
Subjects from Arms A and B who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose range of 100-140 MBq on either Visit 2(Day 1) or on Visit 3 (Days 16-22).
OG002
Radioactivity Dose Range 160-200 MBq
Subjects from Arms B and C who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose range of 160-200 MBq on either Visit 2 (Day 1) or on Visit 3 (Days 16-22).
Units
Counts
Participants
OG00016
OG00116
OG00216
Title
Denominators
Categories
PET/CT: Peptide mass 5-20 μg (Visit 2)
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0028
Title
Measurements
OG0009
OG00110
OG00210
PET/CT: Peptide mass 30-45 μg (Visit 3)
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0028
Title
Measurements
OG000
PET: Peptide mass 5-20 μg (Visit 2)
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0028
Title
Measurements
OG000
PET: Peptide mass 30-45 μg (Visit 3)
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0028
Title
Measurements
OG000
Arm B: 5-20 μg/100-140 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 100-140 MBq on Visit 2 (Day 1).
OG003
Arm B: 30-45 μg/160-200 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 160-200 MBq on Visit 3 (Days 16 to 22).
OG004
Arm C: 5-20 μg/160-200 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 160-200 MBq.
OG005
Arm C: 30-45 μg/40-80 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 40-80 MBq on Visit 3 (Days 16 to 22).
Units
Counts
Participants
OG0008
OG0018
OG0028
OG0038
OG0048
OG0058
Title
Denominators
Categories
Primary Site
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0032
ParticipantsOG0041
ParticipantsOG0051
Title
Measurements
OG00090.3(44.63 to 136.04)
OG00190.3(43.34 to 137.34)
OG00224.5(16.66 to 86.71)
OG003
Liver
ParticipantsOG0005
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG0035
Lymph Nodes
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0026
ParticipantsOG0036
Bone
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
Lung
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Subjects from Arms A and C who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose of 40-80 MBq on either Visit 2 (Day 1) or on Visit 3 (Days 16-22).
OG003
Radioactivity Dose Range 100-140 MBq
Subjects from Arms A and B who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose range of 100-140 MBq on either Visit 2(Day 1) or on Visit 3 (Days 16-22).
OG004
Radioactivity Dose Range 160-200 MBq
Subjects from Arms B and C who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose range of 160-200 MBq on either Visit 2 (Day 1) or on Visit 3 (Days 16-22).
Units
Counts
Participants
OG00024
OG00124
OG00216
OG00316
OG00416
Title
Denominators
Categories
Primary Site
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0023
ParticipantsOG0035
ParticipantsOG0043
Title
Measurements
OG00034.5(14.19 to 136.04)
OG00143.3(11.93 to 137.34)
OG00244.6(13.67 to 136.04)
OG003
Liver
ParticipantsOG00018
ParticipantsOG00118
ParticipantsOG00213
ParticipantsOG00310
Lymph Nodes
ParticipantsOG00014
ParticipantsOG00114
ParticipantsOG0028
ParticipantsOG0039
Bone
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0031
Lung
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Arm B: 5-20 μg/100-140 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 100-140 MBq on Visit 2 (Day 1).
OG003
Arm B: 30-45 μg/160-200 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 160-200 MBq on Visit 3 (Days 16 to 22).
OG004
Arm C: 5-20 μg/160-200 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 160-200 MBq.
OG005
Arm C: 30-45 μg/40-80 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 40-80 MBq on Visit 3 (Days 16 to 22).
Units
Counts
Participants
OG0008
OG0018
OG0028
OG0038
OG0048
OG0058
Title
Denominators
Categories
PET/CT: Primary Site
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
Title
Measurements
OG0001.0(0 to 1)
OG0011.0(0 to 1)
OG0020.0(0 to 1)
OG003
PET/CT: Liver
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0027
ParticipantsOG0037
PET/CT: Lymph Nodes
ParticipantsOG0007
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG0037
PET/CT: Bone
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0027
ParticipantsOG0037
PET/CT: Lung
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0025
ParticipantsOG0035
PET: Primary Site
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0038
PET: Liver
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0027
ParticipantsOG0037
PET: Lymph Nodes
ParticipantsOG0007
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG0037
PET: Bone
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0027
ParticipantsOG0037
PET: Lung
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0025
ParticipantsOG0035
Subjects from Arms A and C who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose of 40-80 MBq on either Visit 2 (Day 1) or on Visit 3 (Days 16-22).
OG003
Radioactivity Dose Range 100-140 MBq
Subjects from Arms A and B who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose range of 100-140 MBq on either Visit 2(Day 1) or on Visit 3 (Days 16-22).
OG004
Radioactivity Dose Range 160-200 MBq
Subjects from Arms B and C who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose range of 160-200 MBq on either Visit 2 (Day 1) or on Visit 3 (Days 16-22).
Units
Counts
Participants
OG00024
OG00124
OG00216
OG00316
OG00416
Title
Denominators
Categories
PET/CT: Primary Site
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00216
ParticipantsOG00316
ParticipantsOG00416
Title
Measurements
OG0001.0(0 to 1)
OG0011.0(0 to 1)
OG0021.0(0 to 1)
OG003
PET/CT: Liver
ParticipantsOG00023
ParticipantsOG00123
ParticipantsOG00216
ParticipantsOG00315
PET/CT: Lymph Nodes
ParticipantsOG00022
ParticipantsOG00122
ParticipantsOG00215
ParticipantsOG00314
PET/CT: Bone
ParticipantsOG00014
ParticipantsOG00114
ParticipantsOG0027
ParticipantsOG00310
PET/CT: Lung
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG0027
ParticipantsOG0039
PET: Primary Site
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00216
ParticipantsOG00316
PET: Liver
ParticipantsOG00023
ParticipantsOG00123
ParticipantsOG00216
ParticipantsOG00315
PET: Lymph Nodes
ParticipantsOG00022
ParticipantsOG00122
ParticipantsOG00215
ParticipantsOG00314
PET: Bone
ParticipantsOG00014
ParticipantsOG00114
ParticipantsOG0027
ParticipantsOG00310
PET: Lung
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG0027
ParticipantsOG0039
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 100-140 MBq on Visit 3 (Days 16 to 22).
OG002
Arm B: 5-20 μg/100-140 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 100-140 MBq on Visit 2 (Day 1).
OG003
Arm B: 30-45 μg/160-200 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 160-200 MBq on Visit 3 (Days 16 to 22).
OG004
Arm C: 5-20 μg/160-200 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 160-200 MBq.
OG005
Arm C: 30-45 μg/40-80 MBq
Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 40-80 MBq on Visit 3 (Days 16 to 22).
Units
Counts
Participants
OG0008
OG0018
OG0028
OG0038
OG0048
OG0058
Title
Denominators
Categories
PET/CT: Primary Site
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
Title
Measurements
OG0000.5(-1 to 1)
OG0010.5(-1 to 1)
OG0020.0(-1 to 1)
OG003
PET/CT: Liver
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0027
ParticipantsOG0037
PET/CT: Lymph Nodes
ParticipantsOG0007
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG0037
PET/CT: Bone
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0027
ParticipantsOG0037
PET/CT: Lung
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0025
ParticipantsOG0035
PET: Primary Site
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0038
PET: Liver
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0027
ParticipantsOG0037
PET: Lymph Nodes
ParticipantsOG0007
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG0037
PET: Bone
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0027
ParticipantsOG0037
PET: Lung
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0025
ParticipantsOG0035
Subjects from Arms A, B and C who received an injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg on Visit 3 (Days 16-22).
OG002
Radioactivity Dose Range 40-80 MBq
Subjects from Arms A and C who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose of 40-80 MBq on either Visit 2 (Day 1) or on Visit 3 (Days 16-22).
OG003
Radioactivity Dose Range 100-140 MBq
Subjects from Arms A and B who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose range of 100-140 MBq on either Visit 2(Day 1) or on Visit 3 (Days 16-22).
OG004
Radioactivity Dose Range 160-200 MBq
Subjects from Arms B and C who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose range of 160-200 MBq on either Visit 2 (Day 1) or on Visit 3 (Days 16-22).