PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacoki... | NCT01205321

Studies
PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability and Diagnostic Performance of BAY86-7548 in Patients With Prostate Cancer and Healthy Volunteers

NCT01205321

Sponsor

Lantheus Biosciences Ltd.

Status

Completed

Last Update Posted

Jan 21, 2013Estimated

Enrollment

19Actual

Phase

Phase 1

Conditions

Diagnostic Imaging

Interventions

Bombesin (68Ga) labeled (BAY86-7548)
Bombesin (68Ga) labeled (BAY86-7548)

Countries

Finland
Germany
Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2008-008315-25	EudraCT Number

Official Title

Open-label, Multi Center PET/CT (Positron Emission Tomography/Computed Tomography) Study for Investigation of Safety, Tolerability, Biodistribution and Diagnostic Performance of the 68Ga Labeled PET Tracer BAY86-7548 Following a Single Intravenous Administration of 140 MBq (Corresponding to ≤ 28 µg Mass Dose) in Patients With Prostate Cancer as Well as Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability of the Tracer in PET/CT in Healthy Volunteers

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Nov 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Sep 17, 2010

First Submission Date that Met QC Criteria

Sep 17, 2010

First Posted Date

Sep 20, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2013

Last Update Posted Date

Jan 21, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental		Drug: Bombesin (68Ga) labeled (BAY86-7548)
Arm 2	Experimental		Drug: Bombesin (68Ga) labeled (BAY86-7548)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bombesin (68Ga) labeled (BAY86-7548)	Drug	Cancer patients, single intravenous bolus injection of 140 MBq BAY86-7548 on day one of the treatment period, PET/CT	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual assessment of lesions		Day of study drug administration

Secondary Outcomes

Measure	Description	Time Frame
Quantitative analysis of BAY86-7548 uptake into lesions (Standardized Uptake Values = SUVs)		Day of study drug administration
ECG (significant abnormalities)		At least 3 times until one day after treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy volunteers:
- males, >/=50 and </= 65 years of age
Cancer patients:
- males >/= 45 years of age
- Patients had an MRI of the prostate and/or a positive choline or acetate PET/CT for diagnosis (Note: MRI, choline and acetate PET/CT are optional for primary prostate cancer patients) of recurrence prostate cancer and the primary cancer disease is/ will be histologically confirmed.
- The prostate cancer is histologically confirmed and results of histology are available.
- Patients with primary prostate cancer: >/= 20 percent of biopsy material should be affected by cancer in the histopathological evaluation.
- Patients with primary prostate cancer: Patient is scheduled to undergo prostatectomy.

Exclusion Criteria:

Concurrent severe and/or uncontrolled and/or unstable other medical disease (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of BAY86-7548, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study
Known sensitivity to the study drug or components of the preparation.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

ID	Term
D009369	Neoplasms

ID	Term
D001839	Bombesin
D011356	Product Labeling
C582579	BAY 86-7548

Ancestor Terms

ID	Term
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D009479	Neuropeptides
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D009419	Nerve Tissue Proteins
D011506	Proteins
D000664	Amphibian Venoms
D014688	Venoms
D045424	Complex Mixtures
D014118	Toxins, Biological
D001685	Biological Factors
D019064	Product Packaging
D007221	Industry
D013676	Technology, Industry, and Agriculture

Facility	Status	City	State	ZIP	Country	Contacts
		Turku		FIN-20521	Finland