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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001881-88 | EudraCT Number |
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The purpose of this study is to assess the safety and tolerability of 68Ga-OPS202 used for the diagnosis of gastroenteropancreatic neuroendocrine tumors (GEP NETs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-OPS202 | Experimental | Satoreotide trizoxetan will be administered in two sequentially ascending peptide doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| satoreotide trizoxetan | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reported With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Drug Reactions (ADRs) | An AE was defined as any untoward medical occurrence in a participant administered a IP and which does not necessarily have a causal relationship with this treatment. For this study, all AEs were regarded as 'treatment emergent', i.e., not seen before administration of the IP or, if already present before administration, worsened after start of administration. An SAE was defined as an event that led to death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect. An ADR was defined as an AE with probable, possible or unlikely relationship to the administration of 68Ga-OPS202. | From start of IP administration to end of the study visit (approximately 28 to 36 days) |
| Number of Participants With Clinical Significant Abnormalities in Laboratory Parameters, Vital Signs, Cardiac Safety, Physical Examination, and Required Concomitant Medication | Laboratory assessments included hematology, blood biochemistry and urine analysis. Vital signs included systolic and diastolic blood pressure, heart rate and axillary body temperature. Cardiac safety was assessed by 12-lead ECGs and physical examination included general appearance, head, neck, eyes, ears, nose, throat, respiratory, cardiovascular, gastrointestinal, musculoskeletal, neurological, endocrine, lymphatic, dermatological, psychological/psychiatric, abdomen, and genitourinary body systems. All medications (including herbal products) taken from visit 1 (Day 0) to visit 3 (7-15 days after visit 2 (3-4 weeks after visit 1), end of the study) were recorded in the participant's case report form. | From start of IP administration to end of the study visit (approximately 28 to 36 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Malignant and Benign Lesions Detected for Session 1 | At visit 1, after administration of 15 μg 68Ga-OPS202, a dynamic scan was performed in kidney region over first 30 minutes; static scans were performed from head to sub-inguinal region at 0.5, 1, 2 and 4 h post-injection. At visit 2, after administration of 50 μg 68Ga-OPS202, a static scan was performed from head to sub-inguinal region at 1 h post-injection. A previous somatostatin receptor scan had been performed within 6 months prior to Day 0. Lesions were classified into malignant and benign by readers. Lesion matching was performed between somatostatin receptor scan and 1 h-68Ga-OPS202 receptor scans at visit 1 and visit 2. Number of lesions for each organ/tissue and overall were calculated and absolute numbers reported. Two different read sessions were held to generate data sets for evaluation of target variables. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Basel | CH-4031 | Switzerland |
A total of 12 participants with histologically confirmed gastro-entero-pancreatic neuroendocrine tumors (GEP NET) and a previously performed somatostatin receptor scan were treated in this study. Each participant underwent a screening visit within 28 days prior to receiving the study's investigational product (IP).
This open-label, micro-dosing study with 2 sequentially ascending single peptide doses was conducted in a single study center in Switzerland between 23 June 2014 and 14 January 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Participants received a single dose of the OPS202 peptide (15 [± 5] microgram (μg) on Day 0. All doses were labeled with 68Ga at a fixed dose of 200 megabecquerel (MBq) (± 25%) per injection. 68Ga-OPS202 was administered intravenously over a time period of less than 1 minute prior to three dimensional (3D) positron emission tomography/computed tomography (PET/CT) scan. As per the sequential dosing scheme, on Day 21, participants then received a single dose of 50 (± 15) μg of 68Ga-OPS202 prior to 3D PET/CT. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety analysis set (SAF) included all participants of the full analysis set (FAS) who received the IP, regardless of any protocol deviations.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants received a single dose of the OPS202 peptide (15 [± 5] μg on Day 0. All doses were labeled with 68Ga at a fixed dose of 200 MBq (± 25%) per injection. 68Ga-OPS202 was administered intravenously over a time period of less than 1 minute prior to 3D PET/CT scan. As per the sequential dosing scheme, on Day 21, participants then received a single dose of 50 (± 15) μg of 68Ga-OPS202 prior to 3D PET/CT. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants Reported With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Drug Reactions (ADRs) | An AE was defined as any untoward medical occurrence in a participant administered a IP and which does not necessarily have a causal relationship with this treatment. For this study, all AEs were regarded as 'treatment emergent', i.e., not seen before administration of the IP or, if already present before administration, worsened after start of administration. An SAE was defined as an event that led to death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect. An ADR was defined as an AE with probable, possible or unlikely relationship to the administration of 68Ga-OPS202. | The SAF included all participants of the FAS who received the IP, regardless of any protocol deviations. | Posted | Count of Participants | Participants | No | From start of IP administration to end of the study visit (approximately 28 to 36 days) |
|
From start of IP administration to end of the study visit (approximately 28 to 36 days).
The SAF included all participants of the FAS who received the IP, regardless of any protocol deviations.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | Participants received a single dose of the OPS202 peptide (15 [± 5] μg on Day 0. All doses were labeled with 68Ga at a fixed dose of 200 MBq (± 25%) per injection. 68Ga-OPS202 was administered intravenously over a time period of less than 1 minute prior to 3D PET/CT scan. As per the sequential dosing scheme, on Day 21, participants then received a single dose of 50 (± 15) μg of 68Ga-OPS202 prior to 3D PET/CT. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Ipsen | see email | clinical.trials@ipsen.com |
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| 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21 |
| Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Tumor contrast in PET imaging was determined by qualitative visual analysis. 68Ga-OPS202 binding was present if at least one lesion, regardless of nature, was detected within respective tissue location. Percentages were based on number of participants with available scan at corresponding time point. | At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21 |
| Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 | At visit 1, after administration of 15 μg 68Ga-OPS202, a dynamic scan was performed in kidney region over the first 30 minutes (0-0.5 h); static scans were performed from head to sub-inguinal region at 0.5, 1, 2 and 4 h post-injection. At visit 2, after administration of 50 μg 68Ga-OPS202, a static scan was performed from head to sub-inguinal region at 1 h post-injection. A previous somatostatin receptor scan had been performed within 6 months prior to Day 0. Lesions were classified into malignant and benign lesion by the readers according to their experience. Lesion matching was performed between the somatostatin receptor scan and the 1 h-68Ga-OPS202 receptor scans at visit 1 and visit 2. The mean SUVmax of lesions (mean of all identified lesions in the lymph node and liver) was summarized by nature of the lesions (malignant, benign). Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected. | 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21 |
| Mean SUVmax of Malignant and Benign Lesions for Session 2 | The mean SUVmax of all identified lesions in the respective organ/tissue was determined. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected. | At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21 |
| Mean SUVmax of Reference Tissues (RT) Region of Interests (ROIs) for Session 1 | Lesion matching was performed between somatostatin receptor scan and 1 h-68Ga-OPS202 receptor scans at visit 1 and visit 2. Mean SUVmax of all selected ROIs in corresponding RT was determined. Corresponding RTs were adjacent healthy regions (1 to 3 healthy regions were identified for each lesion), i.e. located in same organ and/or region as lesion. RTs were determined in tissue locations with malignant lesions only. ROIs were also selected in muscle tissue, which was used as an additional reference region. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected. | 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21 |
| Mean SUVmax of RT for Session 2 | The mean SUVmax of all selected ROIs in the corresponding RT was determined. RTs were determined in tissue locations with malignant lesions only. ROIs were also selected in muscle tissue, which was used as an additional reference region. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected. | At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21 |
| Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 | The tumor contrast, i.e. the SUV ratio for tumor (malignant lesion)-to-background (3D-SUV-R) of a single lesion was defined as: 3D-SUV-R = SUVmax of lesion / mean of SUVmax of corresponding RTs. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected. | 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21 |
| The 3D-SUV-R of Malignant Lesions for Session 2 | The tumor contrast, i.e. the SUV ratio for 3D-SUV-R of a single lesion was defined as: 3D-SUV-R = SUVmax of lesion / mean of SUVmax of corresponding RTs. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected. | At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21 |
| Percent Change in 3D-SUV-R of Malignant Lesions | The tumor contrast, i.e. the SUV ratio for 3D-SUV-R of a single lesion was defined as: 3D-SUV-R = SUVmax of lesion / mean of SUVmax of corresponding RT. For percent change, 68Ga-OPS202 receptor scan is compared to previous somatostatin receptor scan. | 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21 |
| Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location | For determining a suitable time window for PET/CT with 68Ga-OPS202, the scans after administration of the 15 μg peptide dose were analyzed and the time point with the highest lesion number per tissue location and overall were determined. If the highest number of lesion was detected at more than one time point, the earliest time point was used. | At 0.5, 1, 2, and 4 hour post-injection on Day 0 |
| Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | The time point with the highest mean 3D-SUV-R per tissue location were determined. If the highest mean 3D-SUV-R was detected at more than one time point, the earliest time point was used. | At 0.5, 1, 2, and 4 hour post-injection on Day 0 |
| Best Diagnostic Scan Assessment | The assessment of every diagnostic 68Ga-OPS202 PET/CT scan of session 2 was rated by the reader from 1 to 5, where 1=worst diagnostic scan and 5=best diagnostic scan. Higher score indicates a better scan. | At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG000 | All Participants | Participants received a single dose of the OPS202 peptide (15 [± 5] μg on Day 0. All doses were labeled with 68Ga at a fixed dose of 200 MBq (± 25%) per injection. 68Ga-OPS202 was administered intravenously over a time period of less than 1 minute prior to 3D PET/CT scan. As per the sequential dosing scheme, on Day 21, participants then received a single dose of 50 (± 15) μg of 68Ga-OPS202 prior to 3D PET/CT. |
|
|
| Primary | Number of Participants With Clinical Significant Abnormalities in Laboratory Parameters, Vital Signs, Cardiac Safety, Physical Examination, and Required Concomitant Medication | Laboratory assessments included hematology, blood biochemistry and urine analysis. Vital signs included systolic and diastolic blood pressure, heart rate and axillary body temperature. Cardiac safety was assessed by 12-lead ECGs and physical examination included general appearance, head, neck, eyes, ears, nose, throat, respiratory, cardiovascular, gastrointestinal, musculoskeletal, neurological, endocrine, lymphatic, dermatological, psychological/psychiatric, abdomen, and genitourinary body systems. All medications (including herbal products) taken from visit 1 (Day 0) to visit 3 (7-15 days after visit 2 (3-4 weeks after visit 1), end of the study) were recorded in the participant's case report form. | The SAF included all participants of the FAS who received the investigational product, regardless of any protocol deviations. | Posted | Count of Participants | Participants | No | From start of IP administration to end of the study visit (approximately 28 to 36 days) |
|
|
|
| Secondary | Number of Malignant and Benign Lesions Detected for Session 1 | At visit 1, after administration of 15 μg 68Ga-OPS202, a dynamic scan was performed in kidney region over first 30 minutes; static scans were performed from head to sub-inguinal region at 0.5, 1, 2 and 4 h post-injection. At visit 2, after administration of 50 μg 68Ga-OPS202, a static scan was performed from head to sub-inguinal region at 1 h post-injection. A previous somatostatin receptor scan had been performed within 6 months prior to Day 0. Lesions were classified into malignant and benign by readers. Lesion matching was performed between somatostatin receptor scan and 1 h-68Ga-OPS202 receptor scans at visit 1 and visit 2. Number of lesions for each organ/tissue and overall were calculated and absolute numbers reported. Two different read sessions were held to generate data sets for evaluation of target variables. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected. | The Intention-to-Treat (ITT) set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations. | Posted | Mean | Standard Deviation | lesion | 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21 |
|
|
|
|
| Secondary | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Tumor contrast in PET imaging was determined by qualitative visual analysis. 68Ga-OPS202 binding was present if at least one lesion, regardless of nature, was detected within respective tissue location. Percentages were based on number of participants with available scan at corresponding time point. | The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations. | Posted | Number | percentage of participants | At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21 |
|
|
|
| Secondary | Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 | At visit 1, after administration of 15 μg 68Ga-OPS202, a dynamic scan was performed in kidney region over the first 30 minutes (0-0.5 h); static scans were performed from head to sub-inguinal region at 0.5, 1, 2 and 4 h post-injection. At visit 2, after administration of 50 μg 68Ga-OPS202, a static scan was performed from head to sub-inguinal region at 1 h post-injection. A previous somatostatin receptor scan had been performed within 6 months prior to Day 0. Lesions were classified into malignant and benign lesion by the readers according to their experience. Lesion matching was performed between the somatostatin receptor scan and the 1 h-68Ga-OPS202 receptor scans at visit 1 and visit 2. The mean SUVmax of lesions (mean of all identified lesions in the lymph node and liver) was summarized by nature of the lesions (malignant, benign). Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected. | The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations. | Posted | Mean | Standard Deviation | SUVmax | 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21 |
|
|
|
|
| Secondary | Mean SUVmax of Malignant and Benign Lesions for Session 2 | The mean SUVmax of all identified lesions in the respective organ/tissue was determined. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected. | The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations. | Posted | Mean | Standard Deviation | SUVmax | At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21 |
|
|
|
|
| Secondary | Mean SUVmax of Reference Tissues (RT) Region of Interests (ROIs) for Session 1 | Lesion matching was performed between somatostatin receptor scan and 1 h-68Ga-OPS202 receptor scans at visit 1 and visit 2. Mean SUVmax of all selected ROIs in corresponding RT was determined. Corresponding RTs were adjacent healthy regions (1 to 3 healthy regions were identified for each lesion), i.e. located in same organ and/or region as lesion. RTs were determined in tissue locations with malignant lesions only. ROIs were also selected in muscle tissue, which was used as an additional reference region. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected. | The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations. | Posted | Mean | Standard Deviation | SUVmax | 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21 |
|
|
|
|
| Secondary | Mean SUVmax of RT for Session 2 | The mean SUVmax of all selected ROIs in the corresponding RT was determined. RTs were determined in tissue locations with malignant lesions only. ROIs were also selected in muscle tissue, which was used as an additional reference region. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected. | The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations. | Posted | Mean | Standard Deviation | SUVmax | At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21 |
|
|
|
|
| Secondary | Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 | The tumor contrast, i.e. the SUV ratio for tumor (malignant lesion)-to-background (3D-SUV-R) of a single lesion was defined as: 3D-SUV-R = SUVmax of lesion / mean of SUVmax of corresponding RTs. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected. | The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations. | Posted | Mean | Standard Deviation | ratio | 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21 |
|
|
|
|
| Secondary | The 3D-SUV-R of Malignant Lesions for Session 2 | The tumor contrast, i.e. the SUV ratio for 3D-SUV-R of a single lesion was defined as: 3D-SUV-R = SUVmax of lesion / mean of SUVmax of corresponding RTs. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected. | The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations. | Posted | Mean | Standard Deviation | ratio | At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21 |
|
|
|
|
| Secondary | Percent Change in 3D-SUV-R of Malignant Lesions | The tumor contrast, i.e. the SUV ratio for 3D-SUV-R of a single lesion was defined as: 3D-SUV-R = SUVmax of lesion / mean of SUVmax of corresponding RT. For percent change, 68Ga-OPS202 receptor scan is compared to previous somatostatin receptor scan. | The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations. | Posted | Mean | Standard Deviation | percent change | 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21 |
|
|
|
| Secondary | Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location | For determining a suitable time window for PET/CT with 68Ga-OPS202, the scans after administration of the 15 μg peptide dose were analyzed and the time point with the highest lesion number per tissue location and overall were determined. If the highest number of lesion was detected at more than one time point, the earliest time point was used. | The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations. | Posted | Count of Participants | Participants | No | At 0.5, 1, 2, and 4 hour post-injection on Day 0 |
|
|
|
| Secondary | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | The time point with the highest mean 3D-SUV-R per tissue location were determined. If the highest mean 3D-SUV-R was detected at more than one time point, the earliest time point was used. | The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations. | Posted | Count of Participants | Participants | No | At 0.5, 1, 2, and 4 hour post-injection on Day 0 |
|
|
|
| Secondary | Best Diagnostic Scan Assessment | The assessment of every diagnostic 68Ga-OPS202 PET/CT scan of session 2 was rated by the reader from 1 to 5, where 1=worst diagnostic scan and 5=best diagnostic scan. Higher score indicates a better scan. | The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations. | Posted | Median | Full Range | score on a scale | At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21 |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 6 |
| 12 |
| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Physical examination abnormalities |
|
| Concomitant medications required |
|
| Malignant: Bone |
|
|
| Malignant: Liver |
|
|
| Malignant: Lymph node |
|
|
| Malignant: Peritoneum |
|
|
| Malignant: Small bowel |
|
|
| Benign: Total |
|
|
| Benign: Lung |
|
|
| Benign: Lymph node |
|
|
| Benign: Mamma |
|
|
| Benign: Mediastinum |
|
|
| Benign: Pancreas |
|
|
| Benign: Small bowel |
|
|
| Benign: Spleen |
|
|
| Benign: Stomach |
|
|
| Benign: Thyroid gland |
|
|
| Wilcoxon signed rank test |
| 0.004 |
| Other |
| Comparison of malignant lesions in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point. | Wilcoxon signed rank test | 0.012 | Other |
| Comparison of malignant lesions in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point. | Wilcoxon signed rank test | 0.004 | Other |
| Comparison of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point. | Wilcoxon signed rank test | 0.500 | Other |
| Comparison of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point. | Wilcoxon signed rank test | 1.000 | Other |
| Total: At 1 hour |
|
|
| Total: At 2 hour |
|
|
| Total: At 4 hour |
|
|
| Bone: At 0.5 hour |
|
|
| Bone: At 1 hour |
|
|
| Bone: At 2 hour |
|
|
| Bone: At 4 hour |
|
|
| Liver: At 0.5 hour |
|
|
| Liver: At 1 hour |
|
|
| Liver: At 2 hour |
|
|
| Liver: At 4 hour |
|
|
| Lung: At 0.5 hour |
|
|
| Lung: At 1 hour |
|
|
| Lung: At 2 hour |
|
|
| Lung: At 4 hour |
|
|
| Lymph node: At 0.5 hour |
|
|
| Lymph node: At 1 hour |
|
|
| Lymph node: At 2 hour |
|
|
| Lymph node: At 4 hour |
|
|
| Mamma: At 0.5 hour |
|
|
| Mamma: At 1 hour |
|
|
| Mamma: At 2 hour |
|
|
| Mamma: At 4 hour |
|
|
| Pancreas: At 0.5 hour |
|
|
| Pancreas: At 1 hour |
|
|
| Pancreas: At 2 hour |
|
|
| Pancreas: At 4 hour |
|
|
| Peritoneum: At 0.5 hour |
|
|
| Peritoneum: At 1 hour |
|
|
| Peritoneum: At 2 hour |
|
|
| Peritoneum: At 4 hour |
|
|
| Small bowel: At 0.5 hour |
|
|
| Small bowel: At 1 hour |
|
|
| Small bowel: At 2 hour |
|
|
| Small bowel: At 4 hour |
|
|
| Thyroid gland: At 0.5 hour |
|
|
| Thyroid gland: At 1 hour |
|
|
| Thyroid gland: At 2 hour |
|
|
| Thyroid gland: At 4 hour |
|
|
| Malignant: Liver |
|
|
| Malignant: Lymph node |
|
|
| Malignant: Peritoneum |
|
|
| Malignant: Small bowel |
|
|
| Benign: Lung |
|
|
| Benign: Lymph node |
|
|
| Benign: Mamma |
|
|
| Benign: Mediastinum |
|
|
| Benign: Pancreas |
|
|
| Benign: Small bowel |
|
|
| Benign: Spleen |
|
|
| Benign: Stomach |
|
|
| Benign: Thyroid gland |
|
|
| Wilcoxon signed rank test |
| 0.004 |
| Other |
| Comparison of SUVmax of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point. | Wilcoxon signed rank test | 0.688 | Other |
| Comparison of SUVmax of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point. | Wilcoxon signed rank test | 0.578 | Other |
| Malignant: Bone: At 1 hour |
|
|
| Malignant: Bone: At 2 hour |
|
|
| Malignant: Bone: At 4 hour |
|
|
| Malignant: Liver: At 0.5 hour |
|
|
| Malignant: Liver: At 1 hour |
|
|
| Malignant: Liver: At 2 hour |
|
|
| Malignant: Liver: At 4 hour |
|
|
| Malignant: Lymph node: At 0.5 hour |
|
|
| Malignant: Lymph node: At 1 hour |
|
|
| Malignant: Lymph node: At 2 hour |
|
|
| Malignant: Lymph node: At 4 hour |
|
|
| Malignant: Peritoneum: At 0.5 hour |
|
|
| Malignant: Peritoneum: At 1 hour |
|
|
| Malignant: Peritoneum: At 2 hour |
|
|
| Malignant: Peritoneum: At 4 hour |
|
|
| Malignant: Small bowel: At 0.5 hour |
|
|
| Malignant: Small bowel: At 1 hour |
|
|
| Malignant: Small bowel: At 2 hour |
|
|
| Malignant: Small bowel: At 4 hour |
|
|
| Benign: Pancreas: At 0.5 hour |
|
|
| Benign: Pancreas: At 1 hour |
|
|
| Benign: Pancreas: At 2 hour |
|
|
| Benign: Pancreas: At 4 hour |
|
|
| Wilcoxon signed rank test |
| 0.219 |
| Other |
| Muscle |
|
|
| Liver |
|
|
| Lymph node |
|
|
| Peritoneum |
|
|
| Small bowel |
|
|
| Wilcoxon signed rank test |
| 0.339 |
| Other |
| Comparison of SUVmax of RT in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point. | Wilcoxon signed rank test | 0.001 | Other |
| Comparison of SUVmax of RT in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point. | Wilcoxon signed rank test | 0.000 | Other |
| Comparison of SUVmax of RT in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point. | Wilcoxon signed rank test | 0.297 | Other |
| Comparison of SUVmax of RT in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point. | Wilcoxon signed rank test | 1.000 | Other |
| Muscle: At 1 hour |
|
|
| Muscle: At 2 hour |
|
|
| Muscle: At 4 hour |
|
|
| Bone: At 0.5 hour |
|
|
| Bone: At 1 hour |
|
|
| Bone: At 2 hour |
|
|
| Bone: At 4 hour |
|
|
| Liver: At 0.5 hour |
|
|
| Liver: At 1 hour |
|
|
| Liver: At 2 hour |
|
|
| Liver: At 4 hour |
|
|
| Lymph node: At 0.5 hour |
|
|
| Lymph node: At 1 hour |
|
|
| Lymph node: At 2 hour |
|
|
| Lymph node: At 4 hour |
|
|
| Peritoneum: At 0.5 hour |
|
|
| Peritoneum: At 1 hour |
|
|
| Peritoneum: At 2 hour |
|
|
| Peritoneum: At 4 hour |
|
|
| Small bowel: At 0.5 hour |
|
|
| Small bowel: At 1 hour |
|
|
| Small bowel: At 2 hour |
|
|
| Small bowel: At 4 hour |
|
|
| Wilcoxon signed rank test |
| 0.233 |
| Other |
| Comparison of SUVmax of RT in lymph node between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point. | Wilcoxon signed rank test | 0.375 | Other |
| Bone (RT: Muscle) |
|
|
| Liver (RT: Liver) |
|
|
| Liver (RT: Muscle) |
|
|
| Lymph node (RT: Lymph node) |
|
|
| Lymph node (RT: Muscle) |
|
|
| Peritoneum (RT: Peritoneum) |
|
|
| Peritoneum (RT: Muscle) |
|
|
| Small bowel (RT: Small bowel) |
|
|
| Small bowel (RT: Muscle) |
|
|
Comparison of 3D-SUV-R of malignant lesions in liver with RT as liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.
| Wilcoxon signed rank test |
| 0.004 |
| Other |
| Comparison of 3D-SUV-R of malignant lesions in liver with RT as muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point. | Wilcoxon signed rank test | 0.426 | Other |
| Comparison of 3D-SUV-R of malignant lesions in liver with RT as muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point. | Wilcoxon signed rank test | 0.098 | Other |
| Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point. | Wilcoxon signed rank test | 0.813 | Other |
| Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point. | Wilcoxon signed rank test | 0.813 | Other |
| Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point. | Wilcoxon signed rank test | 0.297 | Other |
| Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point. | Wilcoxon signed rank test | 0.469 | Other |
| Bone (RT: Bone): At 1 hour |
|
|
| Bone (RT: Bone): At 2 hour |
|
|
| Bone (RT: Bone): At 4 hour |
|
|
| Bone (RT: Muscle): At 0.5 hour |
|
|
| Bone (RT: Muscle): At 1 hour |
|
|
| Bone (RT: Muscle): At 2 hour |
|
|
| Bone (RT: Muscle): At 4 hour |
|
|
| Liver (RT: Liver): At 0.5 hour |
|
|
| Liver (RT: Liver): At 1 hour |
|
|
| Liver (RT: Liver): At 2 hour |
|
|
| Liver (RT: Liver): At 4 hour |
|
|
| Liver (RT: Muscle): At 0.5 hour |
|
|
| Liver (RT: Muscle): At 1 hour |
|
|
| Liver (RT: Muscle): At 2 hour |
|
|
| Liver (RT: Muscle): At 4 hour |
|
|
| Lymph node (RT: Lymph node): At 0.5 hour |
|
|
| Lymph node (RT: Lymph node): At 1 hour |
|
|
| Lymph node (RT: Lymph node): At 2 hour |
|
|
| Lymph node (RT: Lymph node): At 4 hour |
|
|
| Lymph node (RT: Muscle): At 0.5 hour |
|
|
| Lymph node (RT: Muscle): At 1 hour |
|
|
| Lymph node (RT: Muscle): At 2 hour |
|
|
| Lymph node (RT: Muscle): At 4 hour |
|
|
| Peritoneum (RT: Peritoneum): At 0.5 hour |
|
|
| Peritoneum (RT: Peritoneum): At 1 hour |
|
|
| Peritoneum (RT: Peritoneum): At 2 hour |
|
|
| Peritoneum (RT: Peritoneum): At 4 hour |
|
|
| Peritoneum (RT: Muscle): At 0.5 hour |
|
|
| Peritoneum (RT: Muscle): At 1 hour |
|
|
| Peritoneum (RT: Muscle): At 2 hour |
|
|
| Peritoneum (RT: Muscle): At 4 hour |
|
|
| Small bowel (RT: Small bowel): At 0.5 hour |
|
|
| Small bowel (RT: Small bowel): At 1 hour |
|
|
| Small bowel (RT: Small bowel): At 2 hour |
|
|
| Small bowel (RT: Small bowel): At 4 hour |
|
|
| Small bowel (RT: Muscle): At 0.5 hour |
|
|
| Small bowel (RT: Muscle): At 1 hour |
|
|
| Small bowel (RT: Muscle): At 2 hour |
|
|
| Small bowel (RT: Muscle): At 4 hour |
|
|
Comparison of 3D-SUV-R of malignant lesions in liver with RT as muscle between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.
| Wilcoxon signed rank test |
| 0.039 |
| Other |
| Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as lymph node between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point. | Wilcoxon signed rank test | 0.375 | Other |
| Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as muscle between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point. | Wilcoxon signed rank test | 0.219 | Other |
| Bone (RT: Muscle) |
|
|
| Liver (RT: Liver) |
|
|
| Liver (RT: Muscle) |
|
|
| Lymph node (RT: Lymph node) |
|
|
| Lymph node (RT: Muscle) |
|
|
| Peritoneum (RT: Peritoneum) |
|
|
| Peritoneum (RT: Muscle) |
|
|
| Small bowel (RT: Small bowel) |
|
|
| Small bowel (RT: Muscle) |
|
|
| At 2 hour |
|
| At 4 hour |
|
| Bone |
|
|
| Liver |
|
|
| Lung |
|
|
| Lymph node |
|
|
| Mamma |
|
|
| Pancreas |
|
|
| Peritoneum |
|
|
| Small bowel |
|
|
| Thyroid gland |
|
|
| At 2 hour |
|
| At 4 hour |
|
| Bone (RT: Muscle) |
|
|
| Liver (RT: Liver) |
|
|
| Liver (RT: Muscle) |
|
|
| Lymph node (RT: Lymph node) |
|
|
| Lymph node (RT: Muscle) |
|
|
| Mamma (RT: Mamma) |
|
|
| Mamma (RT: Muscle) |
|
|
| Peritoneum (RT: Peritoneum) |
|
|
| Peritoneum (RT: Muscle) |
|
|
| Small bowel (RT: Small bowel) |
|
|
| Small bowel (RT: Muscle) |
|
|
| At 1 hour |
|
|
| At 2 hour |
|
|
| At 4 hour |
|
|