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.

Phase 2

• Conditions: Glioblastoma
• Interventions: Procedure: FDG-PET

• Registration Number: NCT01083719
• Lead Sponsor: Medanta Institute of Clinical Research

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

Not available

Study Timeline

• Status Verified: 2010-03
• Study First Submitted: 2010-03-06
• Study First Submitted QC: 2010-03-09
• Last Update Submitted: 2010-03-09
• Study First Posted: 2010-03-10
• Last Update Posted: 2010-03-10
• Study Start: 2010-04
• Primary Completion: 2011-08
• Study Completion: 2011-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FDG-PET	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.

Primary Outcome Measures

Name	Time	Method
Tumor infiltration defined on FDG-PET not determined to MRI	18 months