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

February 23, 2009
August 31, 2012
October 2008
July 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00850278 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Assessment of [18F]FLT-PET Imaging for Diagnosis and Prognosis of Brain Tumors
Assessment of [18F]FLT-PET Imaging for Diagnosis and Prognosis of Brain Tumors

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Cancer
  • Brain Tumors
Other: FLT-PET imaging
Prior to surgical resection, patient will undergo [11C]MET PET imaging, [18F]FLT PET imaging, MRI, and spectroscopy imaging.
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00850278
2007-006265-32
Yes
University Hospital, Caen
University Hospital, Caen
National Cancer Institute, France
Principal Investigator: Jean-Sébastien Guillamo, MD, PhD University Hospital, Caen
Study Director: Jean-Michel Derlon, Pr University Hospital, Caen
University Hospital, Caen
August 2012

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