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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00943462
Recruitment Status : Withdrawn (No eligible patients could be recruited.)
First Posted : July 22, 2009
Last Update Posted : April 27, 2011
Sponsor:
Collaborator:
Schering-Plough
Information provided by:
Centre hospitalier de l'Université de Montréal (CHUM)

Tracking Information
First Submitted Date July 20, 2009
First Posted Date July 22, 2009
Last Update Posted Date April 27, 2011
Study Start Date June 2009
Estimated Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00943462 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population GBM patients seen at the neuro-oncology clinic of Centre hospitalier de l'Université de Montréal (CHUM)
Condition
  • Astrocytoma, Grade IV
  • Giant Cell Glioblastoma
  • Glioblastoma Multiforme
Intervention
  • 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).
Study Groups/Cohorts 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
  • Drug: Temozolomide
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Estimated Enrollment
 (submitted: July¬†21,¬†2009)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2011
Estimated Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries Canada
 
Administrative Information
NCT Number NCT00943462
Other Study ID Numbers CE-08-234
Schering-P06046
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dre Marie-Andrée Fortin, Centre hospitalier de l'Université de Montréal (CHUM)
Study Sponsor Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators Schering-Plough
Investigators
Principal Investigator: Marie-Andrée Fortin, MD Centre hospitalier de l'Université de Montréal (CHUM)
PRS Account Centre hospitalier de l'Université de Montréal (CHUM)
Verification Date April 2011