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A Comparison of FDG-PET Versus MRI Based Target Volume Delineation in Glioblastoma and the Role of FDG-PET/CT in the Alteration of MRI Based Target Volumes.

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Disease Information

Descriptive Information
Brief Title † A Comparison of FDG-PET Versus MRI Based Target Volume Delineation in Glioblastoma and the Role of FDG-PET/CT in the Alteration of MRI Based Target Volumes.
Official Title † Phase II Study Comparing FDG-PET Versus MRI Based Target Volume Delineation in Glioblastoma and the Role of FDG-PET/CT in the Alteration of MRI Based Target Volumes.
Brief Summary HYPOTHESIS AND SAMPLE SIZE The tumor delineated by FDG-PET is significantly different from the delineation achieved by MR T1 contrast weighted images in glioblastoma; expecting a standard error of 12.5 % (a confidence interval of 25%), with a confidence level set at 95%, a sample size of 15 patients would be accrued in the study.
Detailed Description
Study Phase Phase 2
Study Type † Interventional
Study Design † Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure † Tumor infiltration defined on FDG-PET not determined to MRI
Secondary Outcome Measure †
Condition † Glioblastoma
Intervention † ProcedureFDG-PET
Study Arms / Comparison Groups FDG-PET A comparison of FDG-PET versus MRI based target volume delineation in glioblastoma and the role of FDG-PET/CT in the alteration of MRI based target volumes.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Procedure
Estimated Enrollment † 15
Start Date † April 2010
Completion Date August 2011
Primary Completion Date August 2011
Eligibility Criteria † Inclusion Criteria: 1. Post operative patients of documented high grade gliomas (grade III and IV) 2. Patients who have not undergone any previous irradiation to brain. 3. Performance Scale as defined by ECOG PS 0-3 Exclusion Criteria: 1. Patients who are diabetic. 2. Patients who are pregnant. 3. Any documented contrast allergy to the agents used for imaging. 4. Patients who are unable to comprehend or cooperate effectively for treatment planning.
Gender Both
Ages 18 Years - 70 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries †
Administrative Information
NCT ID † NCT01083719
Organization ID AHD1234
Secondary IDs ††
Responsible Party
Study Sponsor † Medanta Institute of Clinical Research
Collaborators ††
Investigators † : ,
Information Provided By
Verification Date March 2010
First Received Date † March 6, 2010
Last Updated Date March 9, 2010
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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