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

• Status: Withdrawn
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Collaborator: Schering-Plough
• Treatments: Dacarbazine; Temozolomide

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