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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.

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ClinicalTrials.gov Identifier: NCT01083719
Recruitment Status : Unknown
Verified March 2010 by Medanta Institute of Clinical Research.
Recruitment status was:  Not yet recruiting
First Posted : March 10, 2010
Last Update Posted : March 10, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Glioblastoma Procedure: FDG-PET Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : April 2010
Estimated Primary Completion Date : August 2011
Estimated Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.
Procedure: FDG-PET
Fluoro-deoxy gluocose-Positron emission tomography for delineating volumes in Glioblastoma



Primary Outcome Measures :
  1. Tumor infiltration defined on FDG-PET not determined to MRI [ Time Frame: 18 months ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Responsible Party: Dr. Tejinder kataria/ principal Investigator, Medanta- The medicity
ClinicalTrials.gov Identifier: NCT01083719     History of Changes
Other Study ID Numbers: AHD1234
First Posted: March 10, 2010    Key Record Dates
Last Update Posted: March 10, 2010
Last Verified: March 2010

Keywords provided by Medanta Institute of Clinical Research:
Glioblastoma
FDG-PET
MRI

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue