Cancer Clinical Trial
— FLTOfficial title:
Assessment of [18F]FLT-PET Imaging for Diagnosis and Prognosis of Brain Tumors
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 Tomography (PET) imaging for the tumor diagnosis and prognosis in a group of 50 patients with different type of brain tumors.[F-18]FLT PET imaging will be compared to the current used imaging techniques of MRI, spectroscopy imaging, PET imaging using [11C]MET tracer, immunohistochemical analysis and clinical parameters.
Status | Completed |
Enrollment | 50 |
Est. completion date | July 2011 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
France | Caen University Hospital | Caen |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Caen | National Cancer Institute, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluated the aggressive potential of brain tumors related to cell proliferation index measured by [18F]FLT | Day 10 | No | |
Secondary | To compare the efficiency of [18F]FLT with [11C]MET | Day 15 | No | |
Secondary | To define relations between [18F]FLT uptake and clinical, histological and radiological parameters | Day 90 | No | |
Secondary | To define relations between [18F]FLT uptake and patient survival | J90 | No |
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