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 because the information has not been verified recently.
Verified March 2010 by Medanta Institute of Clinical Research.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Medanta Institute of Clinical Research
ClinicalTrials.gov Identifier:
NCT01083719
First received: March 6, 2010
Last updated: March 9, 2010
Last verified: March 2010
  Purpose

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: 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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Dr. Tejinder kataria/ principal Investigator, Medanta- The medicity
ClinicalTrials.gov Identifier: NCT01083719     History of Changes
Other Study ID Numbers: AHD1234
Study First Received: March 6, 2010
Last Updated: March 9, 2010
Health Authority: India: Indian Council of Medical Research

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

ClinicalTrials.gov processed this record on July 22, 2014