Status:
WITHDRAWN
Study of 18F-FEC for Positron Emission Tomography-Computed Tomography (PET-CT) Imaging of GBM
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborating Sponsors:
Schering-Plough
Conditions:
Astrocytoma, Grade IV
Giant Cell Glioblastoma
Eligibility:
All Genders
18-70 years
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00943462
Start Date
June 1 2009
End Date
June 1 2011
Last Update
July 23 2020
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