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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Glioblastoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

FDG-PET

Intervention Type PROCEDURE

Fluoro-deoxy gluocose-Positron emission tomography for delineating volumes in Glioblastoma

Interventions

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FDG-PET

Fluoro-deoxy gluocose-Positron emission tomography for delineating volumes in Glioblastoma

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No