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

NCT ID: NCT01205321

Last Updated: 2013-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2011-12-31

Brief Summary

Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY86-7548 in patients with cancer.

Conditions

Diagnostic Imaging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

Bombesin (68Ga) labeled (BAY86-7548)

Intervention Type: DRUG

Cancer patients, single intravenous bolus injection of 140 MBq BAY86-7548 on day one of the treatment period, PET/CT

Arm 2

Group Type: EXPERIMENTAL

Bombesin (68Ga) labeled (BAY86-7548)

Intervention Type: DRUG

Healthy volunteers, single intravenous bolus injection of 140 MBq BAY86-7548 on day one of the treatment period, whole body PET/CT for determination of effective dose, kinetics of BAY86-7548 in blood

Interventions

Bombesin (68Ga) labeled (BAY86-7548)

Cancer patients, single intravenous bolus injection of 140 MBq BAY86-7548 on day one of the treatment period, PET/CT

Intervention Type: DRUG

Bombesin (68Ga) labeled (BAY86-7548)

Healthy volunteers, single intravenous bolus injection of 140 MBq BAY86-7548 on day one of the treatment period, whole body PET/CT for determination of effective dose, kinetics of BAY86-7548 in blood

Intervention Type: DRUG

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.

• Minimum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Life Molecular Imaging SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Turku, , Finland

Ulm, Baden-Wurttemberg, Germany

Zurich, Canton of Zurich, Switzerland

Countries

Finland; Germany; Switzerland

Other Identifiers

2008-008315-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

14269

Identifier Type: -

Identifier Source: org_study_id