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.

Medanta Institute of Clinical Research

Status and phase: Unknown; Phase 2

Conditions: Glioblastoma

Treatments: Procedure: FDG-PET

Study type: Interventional

Funder types: Other

Identifiers

NCT01083719

AHD1234

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

FDG-PET

Experimental group

Description:

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.

Treatment:

Procedure: FDG-PET