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

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute, France

Information provided by (Responsible Party):

University Hospital, Caen

ClinicalTrials.gov Identifier:

NCT00850278

First received: February 23, 2009

Last updated: August 31, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 23, 2009

Last Updated Date

August 31, 2012

Start Date ^ICMJE

October 2008

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To evaluated the aggressive potential of brain tumors related to cell proliferation index measured by [18F]FLT [ Time Frame: Day 10 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00850278 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To compare the efficiency of [18F]FLT with [11C]MET [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
To define relations between [18F]FLT uptake and clinical, histological and radiological parameters [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
To define relations between [18F]FLT uptake and patient survival [ Time Frame: J90 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

To compare the efficiency of [18F]FLT with [11C]MET [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
To define relations between [18F]FLT uptake and clinical, histological and radiological parameters [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
To define relations between [18F]FLT uptake and patient survival [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Cancer
Brain Tumors

Intervention ^ICMJE

Other: FLT-PET imaging

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

Study Arm (s)

Experimental: FLT-PET imaging

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

Intervention: Other: FLT-PET imaging

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2011

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00850278

Other Study ID Numbers ^ICMJE

2007-006265-32

Has Data Monitoring Committee

Yes

Responsible Party

University Hospital, Caen

Study Sponsor ^ICMJE

University Hospital, Caen

Collaborators ^ICMJE

National Cancer Institute, France

Investigators ^ICMJE

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

Information Provided By

University Hospital, Caen

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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