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
Recruitment status was Not yet recruiting
Sponsor:
Medanta Institute of Clinical Research
Information provided by:
Medanta Institute of Clinical Research
ClinicalTrials.gov Identifier:
NCT01083719
First received: March 6, 2010
Last updated: March 9, 2010
Last verified: March 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Glioblastoma |
Procedure: FDG-PET |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by Medanta Institute of Clinical Research:
Primary Outcome Measures:
- Tumor infiltration defined on FDG-PET not determined to MRI [ Time Frame: 18 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 15 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | August 2011 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Procedure: FDG-PET
Fluoro-deoxy gluocose-Positron emission tomography for delineating volumes in Glioblastoma
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Dr. Tejinder kataria/ principal Investigator, Medanta- The medicity |
| ClinicalTrials.gov Identifier: | NCT01083719 History of Changes |
| Other Study ID Numbers: | AHD1234 |
| Study First Received: | March 6, 2010 |
| Last Updated: | March 9, 2010 |
| Health Authority: | India: Indian Council of Medical Research |
Keywords provided by Medanta Institute of Clinical Research:
|
Glioblastoma FDG-PET MRI |
Additional relevant MeSH terms:
|
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
ClinicalTrials.gov processed this record on May 19, 2013