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

Bayer

Status and phase

Terminated

Phase 1

Conditions

Diagnostic Imaging

Treatments

Drug: BAY86-4367

Study type

Interventional

Funder types

Industry

Identifiers

NCT00975299

13991

2008-007460-42 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

16 patients

Sex

Male

Ages

45+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

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.