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Study of 18F-FEC for Positron Emission Tomography-Computed Tomography (PET-CT) Imaging of GBM

This study has been withdrawn prior to enrollment.
(No eligible patients could be recruited.)
Sponsor:
Collaborator:
Schering-Plough
Information provided by:
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT00943462
First received: July 20, 2009
Last updated: April 26, 2011
Last verified: April 2011
History of Changes

July 20, 2009
April 26, 2011
June 2009
June 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00943462 on ClinicalTrials.gov Archive Site
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Study of 18F-FEC for Positron Emission Tomography-Computed Tomography (PET-CT) Imaging of GBM
Use of PET/CT Imaging With 18F-fluoroethylcholine (FEC) in the Evaluation of Patients Treated With Radiotherapy and Temozolomide Following a Diagnosis of Glioblastoma Multiforme

Positron Emission Tomography-Computed Tomography (PET-CT) with injection of 18F-fluoroethylcholine (FEC) could be a useful tool in the evaluation and follow-up of patients who have been diagnosed with glioblastoma multiforme (GBM) and who are treated with radiotherapy and temozolomide by allowing, for example, the distinction of necrosis from tumour tissue. This tool could help the clinician in making therapeutic decisions for GBM patients.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

GBM patients seen at the neuro-oncology clinic of Centre hospitalier de l'Université de Montréal (CHUM)
  • Astrocytoma, Grade IV
  • Giant Cell Glioblastoma
  • Glioblastoma Multiforme
  • Radiation: External-beam radiation therapy
    60 Gy of external beam radiotherapy using a standard technique will be administered in 2‑Gy fractions, for a total of 30 fractions
  • Drug: Temozolomide
    The chemotherapy will have to be administered in accordance with the protocol used in the CAN-NCIC-CE3 study, which established the current standard for treatment of GBM with the administration of temozolomide as adjuvant therapy at the same time as radiotherapy (clinicaltrials.gov ID NCT00006353).
Glioblastoma Multiforme (GBM)
We will conduct a prospective study on 20 consecutive patients who are seen at the Hôpital Notre‑Dame neuro-oncology clinic for a diagnosis of GBM and who meet our inclusion criteria. We will meet with the eligible patients in order to provide them with a detailed description of the study procedures as well as to have them sign a consent form.
Interventions:
  • Radiation: External-beam radiation therapy
  • Drug: Temozolomide
Stupp R, Hegi ME, Mason WP, van den Bent MJ, Taphoorn MJ, Janzer RC, Ludwin SK, Allgeier A, Fisher B, Belanger K, Hau P, Brandes AA, Gijtenbeek J, Marosi C, Vecht CJ, Mokhtari K, Wesseling P, Villa S, Eisenhauer E, Gorlia T, Weller M, Lacombe D, Cairncross JG, Mirimanoff RO; on behalf of the European Organisation for Research and Treatment of Cancer Brain Tumour and Radiation Oncology Groups; the National Cancer Institute of Canada Clinical Trials Group. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncol. 2009 Mar 6; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
20
June 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Age between 18 and 70 years of age
  • Histological diagnosis of GBM (grade IV astrocytoma based on the World Health Organization [WHO] classification)
  • No previous radiotherapy or chemotherapy
  • No history of previous neoplasms
  • Inoperable patients (tumour in place, biopsy only)
  • KPS ≥ 70

  • Adequate hematological, renal and hepatic function

    • Absolute neutrophil count ≥ 1,500/mm3
    • Platelets ≥ 100,000 per mm3
    • Serum creatinine ≤ 1.5 times the upper limit of normal of the laboratory where it is measured
    • Total bilirubin ≤ 1.5 times the upper limit of normal of the laboratory where it is measured
    • Liver enzymes < 3 times the upper limit of normal of the laboratory where they are measured
  • Patients under corticosteroids must have received a stable or decreasing dose in the 14 days preceding randomization
  • Consent form signed by the patients
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00943462
CE-08-234, Schering-P06046
No
Dre Marie-Andrée Fortin, Centre hospitalier de l'Université de Montréal (CHUM)
Centre hospitalier de l'Université de Montréal (CHUM)
Schering-Plough
Principal Investigator: Marie-Andrée Fortin, MD Centre Hospitalier de l'Université de Montréal
Centre hospitalier de l'Université de Montréal (CHUM)
April 2011

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