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

February 15, 2008
May 3, 2012
February 2008
November 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00624728 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Assessment of 18FLT PET-CT for Volume Definition of High-grade Gliomas (GLIO-TEP)
Assessment of 18Fluoro-thymidine PET-CT for the Volume Definition of High-grade Gliomas (GLIO-TEP) : Correlation With Histopathology

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.

  • 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.
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • High-grade Glioma
  • Astrocytoma
  • Glioblastoma
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.

Experimental: A
Intervention: Radiation: 18F Fluorothymidine PET CT

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00624728
9420-04, 2004-033
Yes
University Hospital, Bordeaux
University Hospital, Bordeaux
Not Provided
Principal Investigator: Fernandez Philippe, Dr University Hospital, Bordeaux, France
Study Chair: Perez Paul, Dr University Hospital, Bordeaux, France
University Hospital, Bordeaux
May 2012

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