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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.

Primary Purpose

Glioblastoma

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
FDG-PET
Sponsored by
Medanta Institute of Clinical Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma focused on measuring Glioblastoma, FDG-PET, MRI

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    FDG-PET

    Arm 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.

    Outcomes

    Primary Outcome Measures

    Tumor infiltration defined on FDG-PET not determined to MRI

    Secondary Outcome Measures

    Full Information

    First Posted
    March 6, 2010
    Last Updated
    March 9, 2010
    Sponsor
    Medanta Institute of Clinical Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01083719
    Brief Title
    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.
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2010
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2010 (undefined)
    Primary Completion Date
    August 2011 (Anticipated)
    Study Completion Date
    August 2011 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Medanta Institute of Clinical Research

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glioblastoma
    Keywords
    Glioblastoma, FDG-PET, MRI

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    FDG-PET
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Procedure
    Intervention Name(s)
    FDG-PET
    Intervention Description
    Fluoro-deoxy gluocose-Positron emission tomography for delineating volumes in Glioblastoma
    Primary Outcome Measure Information:
    Title
    Tumor infiltration defined on FDG-PET not determined to MRI
    Time Frame
    18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Post operative patients of documented high grade gliomas (grade III and IV) Patients who have not undergone any previous irradiation to brain. Performance Scale as defined by ECOG PS 0-3 Exclusion Criteria: Patients who are diabetic. Patients who are pregnant. Any documented contrast allergy to the agents used for imaging. Patients who are unable to comprehend or cooperate effectively for treatment planning.

    12. IPD Sharing Statement

    Learn more about this trial

    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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