Open-label, multicenter study of the 18F labeled PET/CT (positron emission tomography / computed tomography) tracer BAY 86-9596 following a single intravenous administration of 200 or 300 MBq (corresponding to <= 18 µg mass dose), for evaluation of radiation dosimetry, plasma pharmacokinetics, safety and tolerability in healthy volunteers (200 MBq) as well as investigation of safety, tolerability and diagnostic performance in patients (300 MBq) with non small cell long cancer, breast cancer, hea

BAY 86-9596 is not registered as a medicine. BAY 86-9596 is a drug that is
being developed for the diagnosis of different kind of cancers (non small lung
cell lung cancer, breast cancer and head and neck cancer) using a PET-scan. In
particular to differentiate between the new drug BAY 86-9596 and the current
used method (FDG) for the above mentioned cancers and inflammations occurring
in the body. This should lead to improvements in diagnosis for future cancer
patients.

Primary objective:
Explorative investigation of the tumor detection rate with BAY 86-9596 in
comparison to that of 18F-fluorodeoxyglucose (FDG)

Secondary objectives:
- Determination of radiation dosimetry and pharmacokinetics of BAY 86-9596 in
healthy volunteers as well as orientating search for any metabolites using TLC
- Evaluation of BAY 86-9596 compared to FDG in patients with cancer and
inflammation
- Evaluation of safety and tolerability of bAY 86-9596 in patients and healthy
volunteers

Open label, multicenter, single-dose, explorative radiation dosimetry and
diagnostic study in (i) healthy volunteers and (ii) patients with cancer as
well as patients with inflammation showing lesions in previously performed FDG
PET/CT.

The study will start with a screening. At the screening a physical examination
will take place and a few other standard medical assessments will be performed
(ECG, vital signs). Furthermore a blood and urine sample will be taken for
laboratory tests. For patients: a pregnancy test if applicable.

Study healthy volunteers: predose assessments will be done ( determination body
weight, physical examination, a blood and urine sample will be taken for
laboratory tests, ECG, vital signs). On day 1 the subjects will receive BAY
86-9596 and 3 PET and 3 PET/CT scans will be done. On several time points blood
will be taken and urine will be collected. The subjects will be asked for
possible side effects on regular basis. Furthermore ECG, vital signs, blood and
urine safety examinations will be done on day 1 and day 2.

Study patients: predose assessments will be done ( determination body weight,
physical examination, a blood and urine sample will be taken for laboratory
tests, ECG, vital signs and a pregnancy test if applicable). On day 1 the
subjects will receive BAY 86-9596 and 1 PET/CT acquisition will be done. The
subjects will be asked for possible side effects on regular basis. Furthermore
ECG, vital signs, blood and urine safety examinations will be done on day 1 and
day 2.

Finally a follow-up call will be done and normally end the study. Home
pregnancy test for female patients if applicable.

In this trial, BAY 86-9596 will be used in humans for the first time. Animal
studies have yielded no evidence of likely side effects. Theoretically, as with
any substance which does not occur naturally in the body, it is not possible to
rule out completely the possibility of BAY 86-9596 having side effects,
including hypersensitivity reactions and even severe allergic shock.

The radiation exposure associated with the radioactivity of the 18F-labelled
BAY 86-9596 and the x-rays used in the CT scans is of the same magnitude as
that associated with PET/CT studies performed routinely in hospitals. The
radiation-related risks are low, however, and medically justifiable.