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

Centre hospitalier de l'Université de Montréal (CHUM)

Overview

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.

Study Type

OBSERVATIONAL

Conditions

Astrocytoma, Grade IV Giant Cell Glioblastoma Glioblastoma Multiforme

Interventions

External-beam radiation therapyRADIATION

60 Gy of external beam radiotherapy using a standard technique will be administered in 2-Gy fractions, for a total of 30 fractions

TemozolomideDRUG

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

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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