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NCT01083719 Clinical Trial

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.

Glioblastoma Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01083719
Other study ID # AHD1234
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received March 6, 2010
Last updated March 9, 2010
Start date April 2010
Est. completion date August 2011

Study information
Verified date March 2010
Source Medanta Institute of Clinical Research
Contact n/a
Is FDA regulated No
Health authority India: Indian Council of Medical Research
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 15
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• FDG-PET
Fluoro-deoxy gluocose-Positron emission tomography for delineating volumes in Glioblastoma

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Medanta Institute of Clinical Research

Outcome
Type Measure Description Time frame Safety issue
Primary Tumor infiltration defined on FDG-PET not determined to MRI 18 months No
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