Status:
TERMINATED
Positron Emission Tomography/Computed Tomography (PET/CT) Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability and Diagnostic Performance of BAY86-4367 in Patients With Prostate Cancer and Healthy Volunteers
Lead Sponsor:
Bayer
Conditions:
Diagnostic Imaging
Eligibility:
MALE
45+ years
Phase:
PHASE1
Brief Summary
Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY86-4367 in patients with cancer
Eligibility Criteria
Inclusion
- Healthy volunteers:
- males, \>/=50 and \<= 65 years of age
- Cancer patients:
- males \>/= 45 years of age
- patients with recurrent prostate cancer had a positive choline PET/CT for detection, or staging, or restaging of cancer, evaluation of the primary prostate cancer detection rate with BAY 86-4367 in comparison to histology as standard of truth (choline PET/CT is optional).
Exclusion
- Exclusion criteria for all healthy volunteers and patients:
- 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 BAY 86-4367, 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00975299
Start Date
September 1 2009
End Date
October 1 2010
Last Update
June 26 2014
Active Locations (2)
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1
München, Bavaria, Germany, 81675
2
Zurich, Canton of Zurich, Switzerland, 8091