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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Neoplasms
Brain Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Nervous System Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014