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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.

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2010 by Medanta Institute of Clinical Research.
Recruitment status was:  Not yet recruiting
ClinicalTrials.gov Identifier:
First Posted: March 10, 2010
Last Update Posted: March 10, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medanta Institute of Clinical Research
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 Intervention Phase
Glioblastoma Procedure: FDG-PET Phase 2

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:

Further study details as provided by Medanta Institute of Clinical Research:

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

Estimated Enrollment: 15
Study Start Date: April 2010
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Dr. Tejinder kataria/ principal Investigator, Medanta- The medicity
ClinicalTrials.gov Identifier: NCT01083719     History of Changes
Other Study ID Numbers: AHD1234
First Submitted: March 6, 2010
First Posted: March 10, 2010
Last Update Posted: March 10, 2010
Last Verified: March 2010

Keywords provided by Medanta Institute of Clinical Research:

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