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

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ClinicalTrials.gov Identifier: NCT00943462
Recruitment Status : Withdrawn (No eligible patients could be recruited.)
First Posted : July 22, 2009
Last Update Posted : April 27, 2011
Sponsor:
Collaborator:
Schering-Plough
Information provided by:
Centre hospitalier de l'Université de Montréal (CHUM)

Brief Summary:
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 or disease Intervention/treatment
Astrocytoma, Grade IV Giant Cell Glioblastoma Glioblastoma Multiforme Radiation: External-beam radiation therapy Drug: Temozolomide

Study Type : Observational
Estimated Enrollment : 20 participants
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
Study Start Date : June 2009
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : June 2011

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Group/Cohort Intervention/treatment
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).





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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 (CHUM)

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
First Posted: July 22, 2009    Key Record Dates
Last Update Posted: April 27, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents