Radiation Dosimetry, Metabolism, Pharmacokinetics, Safety and Tolerability and PET Imaging With BAY94-9392 in Healthy Volunteers and Patients With Cancer or Inflammation

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.

Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY94-9392 in patients with cancer or inflammation.

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