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.

• Sponsor: Medanta Institute of Clinical Research (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01083719
• Collaborator: (none)
• Enrollment: 15
• Arm: 1
• Duration (Months): 16

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glioblastoma	Procedure: FDG-PET	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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.
• Study Start Date: Apr 1, 2010
• Anticipated Primary Completion Date: Aug 1, 2011
• Anticipated Study Completion Date: Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Tumor infiltration defined on FDG-PET not determined to MRI [18 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Medanta Institute of Clinical Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01083719
• Other Study ID Numbers: AHD1234
• First Posted: Mar 10, 2010
• Last Update Posted: Mar 10, 2010
• Last Verified: Mar 1, 2010

• Keywords provided by , ,: Glioblastoma; FDG-PET; MRI
• Additional relevant MeSH terms: Glioblastoma

Study Results

No Results Posted as of Mar 10, 2010