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

Centre hospitalier de l'Université de Montréal (CHUM)

Status: Withdrawn

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

Treatments: Radiation: External-beam radiation therapy; Drug: Temozolomide

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00943462

Schering-P06046

CE-08-234

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

0 participants in 1 patient group

Glioblastoma Multiforme (GBM)

Description:

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.

Treatment:

Radiation: External-beam radiation therapy

Drug: Temozolomide