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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Astrocytoma, Grade IV, Giant Cell Glioblastoma, Glioblastoma Multiforme

Intervention / Treatment
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* Radiation: External-beam radiation therapy
* Drug: Temozolomide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Glioblastoma Multiforme (GBM)<br>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<br>* 60 Gy of external beam radiotherapy using a standard technique will be administered in 2-Gy fractions, for a total of 30 fractions<br>Drug: Temozolomide<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |