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

Not Applicable

Completed

• Conditions: Cancer; Brain Tumors
• Interventions: Other: FLT-PET imaging

• Registration Number: NCT00850278
• Lead Sponsor: University Hospital, Caen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-02-23
• Study First Submitted QC: 2009-02-23
• Study First Posted: 2009-02-24
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-31
• Last Update Posted: 2012-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
To evaluated the aggressive potential of brain tumors related to cell proliferation index measured by [18F]FLT	Day 10

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Caen University Hospital; 🇫🇷 Caen, France