Status:
COMPLETED
PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability and Diagnostic Performance of BAY86-7548 in Patients With Prostate Cancer and Healthy Volunteers
Lead Sponsor:
Life Molecular Imaging SA
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 BAY86-7548 in patients with cancer.
Eligibility Criteria
Inclusion
- Healthy volunteers:
- males, \>/=50 and \</= 65 years of age
- Cancer patients:
- males \>/= 45 years of age
- Patients had an MRI of the prostate and/or a positive choline or acetate PET/CT for diagnosis (Note: MRI, choline and acetate PET/CT are optional for primary prostate cancer patients) of recurrence prostate cancer and the primary cancer disease is/ will be histologically confirmed.
- The prostate cancer is histologically confirmed and results of histology are available.
- Patients with primary prostate cancer: \>/= 20 percent of biopsy material should be affected by cancer in the histopathological evaluation.
- Patients with primary prostate cancer: Patient is scheduled to undergo prostatectomy.
Exclusion
- 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 BAY86-7548, 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 :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01205321
Start Date
November 1 2010
End Date
December 1 2011
Last Update
January 21 2013
Active Locations (3)
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1
Turku, Finland, FIN-20521
2
Ulm, Baden-Wurttemberg, Germany, 89081
3
Zurich, Canton of Zurich, Switzerland, 8091