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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00943462
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Centre hospitalier de l'Université de Montréal (CHUM)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Marie-Andrée Fortin, MD
Principal Investigator Affiliation Centre hospitalier de l'Université de Montréal (CHUM)
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, Industry
Overall Status Withdrawn
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Astrocytoma, Grade IV, Giant Cell Glioblastoma, Glioblastoma Multiforme
Arms & Interventions

Arms

: Glioblastoma Multiforme (GBM)

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.

Interventions

Radiation: - External-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

Drug: - Temozolomide

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).

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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