Open-label Study for an Exploration of Tumor Accumulation of the 18F Labeled PET/CT (Positron Emission Tomography / Computed Tomography) Tracer BAY94-9392 Following a Single Intravenous Administration of 300 MBq (Corresponding to = 0.1 mg Total Quantity) in Patients With Prostate Cancer or Other Malignant Tumors
Inclusion Criteria:
- Males/females >/= 18 years
- Patients with a diagnosis of primary prostate cancer (biopsy proven) and scheduled
for radical prostatectomy or patients with prostate tumor recurrence (Patients with
advanced tumor disease and a high likelihood to display lymph node metastasis are to
be preferably included.)
- ECOG (Eastern Cooperative Oncology Group) performance status of 0-2, determined
within one week prior to treatment with BAY94-9392
- Patient had an [18F]-fluorodeoxyglucose (FDG) PET/CT for detection, or staging, or
restaging, or therapy response assessment that still showed tumor mass with high
certainty for a cancer such as melanoma, or colorectal cancer, or head & neck cancer
for which FDG-PET/CT is used in clinical routine, and the primary cancer disease is
histologically confirmed. In case of recurrent disease confirmation of the primary
tumor is sufficient
- No clinically relevant deviations in renal function as determined by Cockcroft and
Gault method using serum creatinine at screening.
Exclusion Criteria:
- Concurrent severe and/or uncontrolled and/or unstable medical disease other than
cancer or inflammation (e.g. poorly controlled diabetes, congestive heart failure,
myocardial infarction within 12 months prior to planned injection of BAY94-9392,
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
- Previous treatment with BAY94-9392 in this study