Positron Emission Tomography/Computed Tomography (PET/CT) Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability and Diagnostic Performance of BAY86-4367 in Patients With Prostate Cancer and Healthy Volunteers
Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY86-4367 in patients with cancer
- Healthy volunteers: -- males, >/=50 and <= 65 years of age - Cancer patients: -- males >/= 45 years of age -- patients with recurrent prostate cancer had a positive choline PET/CT for detection, or staging, or restaging of cancer, evaluation of the primary prostate cancer detection rate with BAY 86-4367 in comparison to histology as standard of truth (choline PET/CT is optional).
- Exclusion criteria for all healthy volunteers and patients: -- 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 BAY 86-4367, 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.
Open-label, multicenter PET/CT (positron emission tomography/computed tomography) study for investigation of safety, tolerability, biodistribution and diagnostic performance of the 18F labeled PET tracer BAY86-4367 following a single intravenous administration of 300 MBq (corresponding to </= 40 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