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

August 31, 2012 updated by: University Hospital, Caen
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14033
        • CAEN university Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Collaborators

National Cancer Institute, France

Investigators

  • Principal Investigator: Jean-Sébastien Guillamo, MD, PhD, University Hospital, Caen
  • Study Director: Jean-Michel Derlon, Pr, University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (ACTUAL)

July 1, 2011

Study Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

February 23, 2009

First Submitted That Met QC Criteria

February 23, 2009

First Posted (ESTIMATE)

February 24, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

September 3, 2012

Last Update Submitted That Met QC Criteria

August 31, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-006265-32

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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