Clinical trial NCT00943462: Study of 18F-FEC for Positron Emission Tomography-Computed Tomography (PET-CT) Imaging of GBM
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 type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Astrocytoma, Grade IV
Giant Cell Glioblastoma
Glioblastoma Multiforme
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Schering-Plough
First posted: 2009-07-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: GBM patients seen at the neuro-oncology clinic of 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.


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Marie-Andrée Fortin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stupp R, Hegi ME, Mason WP, van den Bent MJ, Taphoorn MJ, Janzer RC, Ludwin SK, Allgeier A, Fisher B, Belanger K, Hau P, Brandes AA, Gijtenbeek J, Marosi C, Vecht CJ, Mokhtari K, Wesseling P, Villa S, Eisenhauer E, Gorlia T, Weller M, Lacombe D, Cairncross JG, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumour and Radiation Oncology Groups; National Cancer Institute of Canada Clinical Trials Group. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncol. 2009 May;10(5):459-66. doi: 10.1016/S1470-2045(09)70025-7. Epub 2009 Mar 9.