Assessment of [18F]FLT-PET Imaging for Diagnosis and Prognosis of Brain Tumors

Study Overview
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Brief Summary
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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.

Official Title
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Assessment of [18F]FLT-PET Imaging for Diagnosis and Prognosis of Brain Tumors

Conditions
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Cancer, Brain Tumors

Intervention / Treatment
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* Other: FLT-PET imaging


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FLT-PET imaging<br>Prior to surgical resection, patient will undergo [11C]MET PET imaging, [18F]FLT PET imaging, MRI, and spectroscopy imaging. | Other: FLT-PET imaging<br>* Prior to surgical resection, patient will undergo [11C]MET PET imaging, [18F]FLT PET imaging, MRI, and spectroscopy imaging.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluated the aggressive potential of brain tumors related to cell proliferation index measured by [18F]FLT |  | Day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the efficiency of [18F]FLT with [11C]MET |  | Day 15 | 
| To define relations between [18F]FLT uptake and clinical, histological and radiological parameters |  | Day 90 | 
| To define relations between [18F]FLT uptake and patient survival |  | J90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain tumor, [18F]FLT, [11C]MET, TEP-imaging, tumor cell proliferation