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.
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Medanta Institute of Clinical Research.
Recruitment status was Not yet recruiting
Information provided by:
Medanta Institute of Clinical Research
First received: March 6, 2010
Last updated: March 9, 2010
Last verified: March 2010
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.
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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.
Primary Outcome Measures:
- Tumor infiltration defined on FDG-PET not determined to MRI [ Time Frame: 18 months ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||August 2011 (Final data collection date for primary outcome measure)
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.
Fluoro-deoxy gluocose-Positron emission tomography for delineating volumes in Glioblastoma
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Post operative patients of documented high grade gliomas (grade III and IV)
- Patients who have not undergone any previous irradiation to brain.
- Performance Scale as defined by ECOG PS 0-3
- Patients who are diabetic.
- Patients who are pregnant.
- Any documented contrast allergy to the agents used for imaging.
- Patients who are unable to comprehend or cooperate effectively for treatment planning.
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||Dr. Tejinder kataria/ principal Investigator, Medanta- The medicity
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 6, 2010
||March 9, 2010
||India: Indian Council of Medical Research
Keywords provided by Medanta Institute of Clinical Research:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 18, 2014
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue