Open-label, Multi Center Study for an Evaluation of Radiation Dosimetry, Plasma Pharmacokinetics, Safety and Tolerability of the 18F-labeled PET/CT (Positron Emission Tomography / Computed Tomography) Tracer BAY94-9392 Following a Single Intravenous Administration of 300 MBq (Corresponding to ≤ 100 µg Total Quantity) in Healthy Volunteers, as Well as the Investigation of Safety, Tolerability, Pharmacokinetics, and Diagnostic Performance of the Tracer in PET/CT in Cancer Patients or Patients With Inflammation.

Inclusion Criteria

Inclusion criteria:

In Germany Healthy volunteers

- Males/females ≥ 50 and ≤ 65 years Patients

- Males/females ≥ 35 and ≤ 75 years

- histologically confirmed diagnosis of non small cell lung cancer or adenocarcinoma of
the breast with a positive FDG-PET or

- patient with primary prostate cancer scheduled for prostatectomy and patient with
prostate tumor recurrence with a positive choline-PET, the initial disease is
histologically confirmed or

- inflammation with a positive FDG-PET

In Korea Patients

- Males/females ≥ 35 and ≤ 75 years

- histologically confirmed diagnosis of non small cell lung cancer, adenocarcinoma of
the breast or hepatocellular cancer with a positive FDG-PET or

- patient with primary prostate cancer scheduled for prostatectomy and patient with
prostate tumor recurrence with a positive choline-PET, the initial disease is
histologically confirmed or

- inflammation (positive FDG-PET mandatory, could be also done as screening
examination)

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 BAY 94-9392,
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