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Assessment of 18FLT PET-CT for Volume Definition of High-grade Gliomas (GLIO-TEP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00624728
First received: February 15, 2008
Last updated: May 3, 2012
Last verified: May 2012
History of Changes
  Purpose

18F-Fluorothymidine is a recently developed PET tracer to image tumor cell proliferation. Very few data report an interest of using such a tracer for cerebral malignant tumor management. In our project, we want to compare the tumoral volumes obtained with PET and MRI, with the gold standard histopathological diagnosis according to the WHO grading malignancy scale and the Ki-67 proliferation index, for preoperative evaluation as much as for tumoral postoperative residue evaluation. Furthermore, we want to explore the interest of 18F-FLT-PET volume to better delineate tumoral volume in radiotherapeutic management of gliomas.


Condition Intervention Phase
High-grade Glioma
Astrocytoma
Glioblastoma
 Radiation: 18F Fluorothymidine PET CT
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Assessment of 18Fluoro-thymidine PET-CT for the Volume Definition of High-grade Gliomas (GLIO-TEP) : Correlation With Histopathology

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Predictive positive value of PET uptake for detection of malignant tissue (defined with Ki-67 proliferation index >15% in PET+ volumes) [ Time Frame: before and during surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of volumes defined by PET and MRI [ Time Frame: before surgery and 4 weeks after surgery ] [ Designated as safety issue: No ]
  • Description of a quantitative PET proliferation index ("standardized uptake value") [ Time Frame: before surgery and 4 weeks after surgery ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: February 2008
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Radiation: 18F Fluorothymidine PET CT

18 FLT will be provided by the Laboratoire des Radiopharmaceutiques- Université Bordeaux2, Hôpital Xavier Arnozan and prepared according to the method described by Grierson and Shields ( Grierson J, Shields A. Nucl Med Biol 27 :143-156 ; 2000).

Specific activity of 18FLT will be more than 37 GBq/µmol (>1Ci/µmol) corrected for decay at the end of bombardment of cyclotron target. Before tracer injection to patients, each dosis will be tested for pH and for radiochemical purity (> 95%) via HPLC technique and thin layer chromatography.

18FLT dosis will be injected intravenously to the patients (10 mL of salted isotonic solution with less than 10 % (v/v) of ethanol (USP). Administrated activity will be calculated estimating total body surface of patient (2,6 MBq/kg ou 0,07 mCi/kg) with maximal activity of 185 MBq.

PET acquisition will be realized as follows : Dynamic acquisition in 3D mode for 35 min, Iterative reconstruction (OSEM) with and without attenuation correction.

Detailed Description:
  • Background: 18FDG is the most widely used tracer for oncologic positron emission tomography (PET). However, the high glucose utilization of normal gray matter limits its utility in brain explorations. More recently, 18FLT was introduced as a PET tracer for tumor imaging. It has been found useful for non-invasive assessment of the proliferation status of various tumors. Its potential clinical use in the evaluation of brain tumors has not been clearly determined because of sparse studies.
  • The primary objective of this study is to assess the positive predictive value of PET-CT uptake of 18FLT in diagnosing malignant tissue by comparison with the histopathological gold standard diagnosis according to the WHO grading malignancy scale and the Ki-67 proliferation index, at the time of preoperative evaluation.
  • Secondary objectives are: to describe and compare preoperative tumor volumes and postoperative residual tumor volumes as assessed by 18FLT PET-CT and MRI, and to describe a quantitative proliferation index with PET (SUV for "standardized uptake value").
  • Study design: This is an exploratory cross-sectional study at two separate times: pre-and postoperative. Eligible patients will be included consecutively. Histological samples will be analyzed blindly to imaging data. Assessments of PET-CT and MRI volumes will be blind to each other.
  • Procedure: After information and written informed consent and before surgery, patients will undergo MRI and 18F-FLT PET-CT to obtain the tumor volume according to both modalities. Then, surgeons will make different biopsies from i) areas with MR abnormalities and FLT uptake, ii) area with FLT uptake and no MR abnormality (on the surgery approach way or in not functional areas), iii) area with MR abnormality without any FLT uptake, iiii) area without any uptake where biopsy is possible because the area is on the surgery approach way. Then, the samples will be blindly analyzed to determine the Ki-67 proliferation index and WHO grading malignancy scale. Patients will undergo again 18F-FLT PET-TDM and MRI at least 4 weeks after surgery, in the week preceding radiotherapy, to determine residual tumor volumes.
  Eligibility

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

Inclusion Criteria:

  • patients over 18
  • suspicion of malignant glioma on MRI aspect
  • surgical indication with neuronavigation
  • signed informed consent
  • absence of contraindication for MRI
  • absence of pregnancy or breast-feeding

Exclusion Criteria:

  • women : pregnancy or breast-feeding or no oral or intra-uterine contraception (if not post-menopause)
  • secondary exclusion if high grade glioma diagnostic (glioblastoma or astrocytoma grade III) is not confirmed after surgery with histopathology
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00624728

Locations
France
Hôpital Pellegrin-tripode , CHU de Bordeaux
Bordeaux, France, 33076
Hôpital St André, CHU de Bordeaux
Bordeaux, France, 33000
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Fernandez Philippe, Dr University Hospital, Bordeaux, France
Study Chair: Perez Paul, Dr University Hospital, Bordeaux, France
  More Information

Publications:

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00624728     History of Changes
Other Study ID Numbers: 9420-04, 2004-033
Study First Received: February 15, 2008
Last Updated: May 3, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Positron-Emission Tomography
Alovudine [Substance Name]
18F-FLT
 Magnetic Resonance Imaging
Astrocytoma
Glioblastoma

Additional relevant MeSH terms:
Astrocytoma
Glioblastoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on May 19, 2013