Status:
COMPLETED
Assessment of [18F]FLT-PET Imaging for Diagnosis and Prognosis of Brain Tumors
Lead Sponsor:
University Hospital, Caen
Collaborating Sponsors:
National Cancer Institute, France
Conditions:
Cancer
Brain Tumors
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary objective of this study is to assess the efficacy of the radiopharmaceutical 3'-deoxy-3'-\[F-18\]fluorothymidine, \[F-18\]FLT, a tracor of cell proliferation, using Positron Emission Tomog...
Eligibility Criteria
Inclusion
- adults aged between 18 and 70 years
- must have operable grade II, III or IV glioma, recurrent high grade glioma or brain metastases
- KPS \>= 70%
- must have the understanding and ability to sign an informed consent document
- must have adequate liver and kidney function
- be male or non-pregnant, non-lactating females
- patients who are fertile must agree to use an effective method of contraception during participation in the study
- the following laboratory results : absolute neutrophil count \>= 1500 cells/µl, platelet count \>= 100000 cells/µl, SGOT \<= 2.5 x ULN, serum creatinine \<= 1.5 x ULN.
Exclusion
- contraindication to surgery
- concomitant radio-, chemo-, or immunotherapy
- history of significant dementia
- known diagnosis of Human Immunodeficiency Virus (HIV) infection
- patient with hepatitis B or C
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00850278
Start Date
October 1 2008
End Date
July 1 2011
Last Update
September 3 2012
Active Locations (1)
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1
Caen University Hospital
Caen, France, 14033