NCT00624728

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2008

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 27, 2008

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

May 4, 2012

Status Verified

May 1, 2012

Enrollment Period

3.8 years

First QC Date

February 15, 2008

Last Update Submit

May 3, 2012

Conditions

High-grade GliomaAstrocytomaGlioblastoma

Keywords

Positron-Emission TomographyAlovudine [Substance Name]18F-FLTMagnetic Resonance ImagingAstrocytomaGlioblastoma

Outcome Measures

Primary Outcomes (1)

  • Predictive positive value of PET uptake for detection of malignant tissue (defined with Ki-67 proliferation index >15% in PET+ volumes)

    before and during surgery

Secondary Outcomes (2)

  • Comparison of volumes defined by PET and MRI

    before surgery and 4 weeks after surgery

  • Description of a quantitative PET proliferation index ("standardized uptake value")

    before surgery and 4 weeks after surgery

Study Arms (1)

A

EXPERIMENTAL
Radiation: 18F Fluorothymidine PET CT

Interventions

18F Fluorothymidine PET CTRADIATION

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.

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • women : pregnancy or breast-feeding or no oral or intra-uterine contraception (if not post-menopause)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital St André, CHU de Bordeaux

Bordeaux, 33000, France

Location

Hôpital Pellegrin-tripode , CHU de Bordeaux

Bordeaux, 33076, France

Location

Related Publications (2)

  • Choi SJ, Kim JS, Kim JH, Oh SJ, Lee JG, Kim CJ, Ra YS, Yeo JS, Ryu JS, Moon DH. [18F]3'-deoxy-3'-fluorothymidine PET for the diagnosis and grading of brain tumors. Eur J Nucl Med Mol Imaging. 2005 Jun;32(6):653-9. doi: 10.1007/s00259-004-1742-3. Epub 2005 Feb 15.

    PMID: 15711980BACKGROUND

  • Chen W, Cloughesy T, Kamdar N, Satyamurthy N, Bergsneider M, Liau L, Mischel P, Czernin J, Phelps ME, Silverman DH. Imaging proliferation in brain tumors with 18F-FLT PET: comparison with 18F-FDG. J Nucl Med. 2005 Jun;46(6):945-52.

    PMID: 15937304BACKGROUND

MeSH Terms

Conditions

GliomaAstrocytomaGlioblastoma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Fernandez Philippe, Dr

    University Hospital, Bordeaux, France

    PRINCIPAL INVESTIGATOR

  • Perez Paul, Dr

    University Hospital, Bordeaux, France

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2008

First Posted

February 27, 2008

Study Start

February 1, 2008

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

May 4, 2012

Record last verified: 2012-05

Locations

FR(2)