Overview

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

Status:
Completed
Trial end date:
2011-08-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Life Molecular Imaging SA
Piramal Imaging SA
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