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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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition Intervention
Astrocytoma, Grade IV
Giant Cell Glioblastoma
Glioblastoma Multiforme
 Radiation: External-beam radiation therapy
Drug: Temozolomide

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: CT Scans
U.S. FDA Resources

Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Estimated Enrollment: 20
Study Start Date: June 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
 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).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

GBM patients seen at the neuro-oncology clinic of Centre hospitalier de l'Université de Montréal (CHUM)

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00943462

Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Schering-Plough
Investigators
Principal Investigator: Marie-Andrée Fortin, MD Centre Hospitalier de l'Université de Montréal
  More Information

Publications:

Responsible Party: Dre Marie-Andrée Fortin, Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT00943462     History of Changes
Other Study ID Numbers: CE-08-234, Schering-P06046
Study First Received: July 20, 2009
Last Updated: April 26, 2011
Health Authority: Canada: Health Canada

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
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013