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

NCT ID: NCT00850278

Last Updated: 2012-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-07-31

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.

Detailed Description

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Conditions

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Cancer Brain Tumors

Keywords

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Brain tumor [18F]FLT [11C]MET TEP-imaging tumor cell proliferation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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FLT-PET imaging

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

Group Type EXPERIMENTAL

FLT-PET imaging

Intervention Type OTHER

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

Interventions

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FLT-PET imaging

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

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Sébastien Guillamo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Caen

Jean-Michel Derlon, Pr

Role: STUDY_DIRECTOR

University Hospital, Caen

Locations

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Caen University Hospital

Caen, , France

Site Status

Countries

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France

Other Identifiers

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2007-006265-32

Identifier Type: -

Identifier Source: org_study_id