Status:
COMPLETED
Radiation Dosimetry, Metabolism, Safety, Tolerability and Positron Emission Tomography/Computed Tomography (PET/CT) Imaging With BAY 85-8050 in Healthy Volunteers and Patients
Lead Sponsor:
Bayer
Conditions:
Neoplasm
Eligibility:
All Genders
35-75 years
Phase:
PHASE1
Brief Summary
This study is a visual assessment of diagnostic PET/CT images obtained after a single intravenous injection of BAY85-8050 in patients with cancer
Eligibility Criteria
Inclusion
- Healthy volunteers only
- Males/females, \>/=50 and \</= 65 years of age
- Cancer patients only
- Males/females \>/= 35 years and \</= 75 years of age
- Patient had an FDG PET/CT for detection, or staging, or restaging, or therapy response assessment that still showed tumor mass
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 BAY85-8050, 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 :
April 15 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00961831
Start Date
April 15 2009
End Date
December 16 2009
Last Update
October 12 2022
Active Locations (1)
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1
München, Bavaria, Germany, 81675