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Completed

NCT Number: NCT00850278

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Caen University Hospital

Caen, 14033, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FLT-PET imaging

Other

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

Primary outcomes

  1. To evaluated the aggressive potential of brain tumors related to cell proliferation index measured by [18F]FLT

    Time frame: Day 10

Secondary outcomes

  1. To compare the efficiency of [18F]FLT with [11C]MET

    Time frame: Day 15

  2. To define relations between [18F]FLT uptake and clinical, histological and radiological parameters

    Time frame: Day 90

  3. To define relations between [18F]FLT uptake and patient survival

    Time frame: J90

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Collaborators

  • National Cancer Institute, France

Registry information

Acronym: FLT

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Feb 24, 2009
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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