Assessment of [18F]FLT-PET Imaging for Diagnosis and Prognosis of Brain Tumors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital, Caen
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- To evaluated the aggressive potential of brain tumors related to cell proliferation index measured by [18F]FLT
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
FLT-PET imaging
Prior to surgical resection, patient will undergo [11C]MET PET imaging, [18F]FLT PET imaging, MRI, and spectroscopy imaging.
Intervention: FLT-PET imaging (Other)
Outcomes
Primary Outcomes
To evaluated the aggressive potential of brain tumors related to cell proliferation index measured by [18F]FLT
Time Frame: Day 10
Secondary Outcomes
- 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)
- To compare the efficiency of [18F]FLT with [11C]MET(Day 15)