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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

March 6, 2010
March 10, 2010
March 10, 2010
April 2010
August 2011   (Final data collection date for primary outcome measure)
Tumor infiltration defined on FDG-PET not determined to MRI [ Time Frame: 18 months ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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.
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.
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.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Glioblastoma
Procedure: FDG-PET
Fluoro-deoxy gluocose-Positron emission tomography for delineating volumes in Glioblastoma
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.
Intervention: Procedure: FDG-PET
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
15
Same as current
August 2011
August 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01083719
AHD1234
No
Not Provided
Not Provided
Dr. Tejinder kataria/ principal Investigator, Medanta- The medicity
Medanta Institute of Clinical Research
Not Provided
Not Provided
Medanta Institute of Clinical Research
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP