PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Safety and Tolerability in Healthy Volunteers and Safety, Tolerability and Diagnostic Performance of BAY86-9596 in Patients With Non-small Cell Lung Cancer, Breast Cancer, Head and Neck Cancer and Patients With Inflammations

Inclusion criteria

• Healthy volunteers only

• Males/females ≥ 50 years and ≤ 65 years of age
• Cancer patients and inflammation patients (inflammation patients in study part 2 = optional, in study part 3 mandatory)

• Males/females ≥ 30 and ≤ 80 years of age
• patients had an FDG PET/CT for detection, or staging, or restaging, or therapy response assessment that still showed tumor mass with high certainty, for

• NSCLC (non small cell lung cancer), or
• adenocarcinoma of the breast (female patients) or
• squamous cell cancer of head and neck and the cancer disease is histologically confirmed.
• Patients with confirmed/known inflammatory focus/foci after FDG-PET/CT imaging

Exclusion criteria

• Exclusion criteria for all healthy volunteers and patients:

• any concomitant disease (for healthy volunteers) and for patients any 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 BAY86-9596, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study
• For healthy volunteers and patients: known sensitivity to the study drug or components of the preparation.
• tumor patients with known inflammatory disease, where images overlap inflammatory lesions with tumor lesions