Radiation Dosimetry, Metabolism, Pharmacokinetics, Safety and Tolerability and PET Imaging With BAY94-9392 in Healthy Volunteers and Patients With Cancer or Inflammation
Completed · Phase 1
Conditions studied: Diagnostic Imaging, Neoplasms
In brief
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.
Key facts
- Study ID
- NCT01103310
- Run by
- Lantheus Biosciences Ltd.
- People needed
- 46
- Starts
- 2010-04-01
- Expected to finish
- 2011-08-01
- Last updated by the study team
- 2014-11-13
Who can join
Age: 35 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Study site — Stanford, California, United States
- Study site — München, Bavaria, Germany
- Study site — Seoul, South Korea
Full record on ClinicalTrials.gov
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