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

Caen University Hospital

Status: Completed

Conditions: Brain Tumors; Cancer

Treatments: Other: FLT-PET imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT00850278

2007-006265-32

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

FLT-PET imaging

Experimental group

Description:

Prior to surgical resection, patient will undergo \[11C\]MET PET imaging, \[18F\]FLT PET imaging, MRI, and spectroscopy imaging.

Treatment:

Other: FLT-PET imaging