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

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Life Molecular Imaging SA; Piramal Imaging SA
• Treatments: Bombesin; Gastrin-Releasing Peptide

Criteria

Inclusion Criteria:

• Healthy volunteers:

• males, >/=50 and
• 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.