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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.

M

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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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