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

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00943462

Enrollment

Registered

2009-07-22

Start date

2009-06-30

Completion date

2011-06-30

Last updated

2020-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Astrocytoma, Grade IV, Giant Cell Glioblastoma, Glioblastoma Multiforme

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.

Interventions

RADIATIONExternal-beam radiation therapy

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

DRUGTemozolomide

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).

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026