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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
  Purpose

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.


Condition Intervention
Cancer
Brain Tumors
 Other: FLT-PET imaging

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Assessment of [18F]FLT-PET Imaging for Diagnosis and Prognosis of Brain Tumors

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer
U.S. FDA Resources

Further study details as provided by University Hospital, Caen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 50
Study Start Date: October 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00850278

Locations
France
Caen University Hospital
Caen, France, 14033
Sponsors and Collaborators
University Hospital, Caen
National Cancer Institute, France
Investigators
Principal Investigator: Jean-Sébastien Guillamo, MD, PhD University Hospital, Caen
Study Director: Jean-Michel Derlon, Pr University Hospital, Caen
  More Information

No publications provided

Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT00850278     History of Changes
Other Study ID Numbers: 2007-006265-32
Study First Received: February 23, 2009
Last Updated: August 31, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Caen:
Brain tumor
[18F]FLT
[11C]MET
TEP-imaging
tumor cell proliferation

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
 Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 21, 2013