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Determination of Fraction Size Equivalent Dose (FED) Levels for Intracranial Conformal Avoidance Radiotherapy

Sponsor
University of Wisconsin, Madison (Other)
Overall Status
Completed
CT.gov ID
NCT00214175
Collaborator
National Cancer Institute (NCI) (NIH)
44
Enrollment
1
Location
79
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective is to evaluate and quantify the reproducibility of functional magnetic resonance imaging (fMRI) maps of the eloquent brain areas corresponding to specific neurological functions based on activation maps obtained with different thresholds in patients with benign and biopsy proven low-grade brain neoplasms. Another objective is to access the impairment in neurological function in image guided intracranial radiotherapy using neurocognitive assessment tools and to derive dose response curves relating the impairment in a particular neurological function to the FED received by the area of eloquent brain corresponding to it.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    44 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Determination of Fraction Size Equivalent Dose (FED) Levels for Intracranial Conformal Avoidance Radiotherapy
    Study Start Date :
    Jun 1, 2004
    Actual Primary Completion Date :
    Jan 1, 2011
    Actual Study Completion Date :
    Jan 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    patients

    patients who will receive XRT
    matched volunteers

    Spouse or sibling

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      • Indication for brain radiotherapy.

      • Ability to undergo MRI scans and time to participate in neurocognitive testing.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 University of Wisconsin Hospital and Clinics Madison Wisconsin United States 53792

      Sponsors and Collaborators

      • University of Wisconsin, Madison
      • National Cancer Institute (NCI)

      Investigators

      • Principal Investigator: Wolfgang Tome, PhD, University of Wisconsin, Madison

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      University of Wisconsin, Madison
      ClinicalTrials.gov Identifier:
      NCT00214175
      Other Study ID Numbers:
      • RO04323
      • NCI-P01 CA88960
      First Posted:
      Sep 21, 2005
      Last Update Posted:
      Feb 24, 2012
      Last Verified:
      Feb 1, 2012
      Keywords provided by University of Wisconsin, Madison
      low grade gliomas and benign CNS lesions
      Additional relevant MeSH terms:
      Glioma
      Brain Neoplasms

      Study Results

      No Results Posted as of Feb 24, 2012