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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00214175
First received: September 13, 2005
Last updated: February 22, 2012
Last verified: February 2012
History of Changes
  Purpose

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
Glioma
Brain Neoplasms

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Determination of Fraction Size Equivalent Dose (FED) Levels for Intracranial Conformal Avoidance Radiotherapy

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer
U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Enrollment: 44
Study Start Date: June 2004
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
patients
patients who will receive XRT
matched volunteers
Spouse or sibling

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Study patients will come from the population that is referred to radiotherapy for treatment of their low grade glioma or benign brain lesion and will undergo fractionated radiotherapy. The volunteers will be a spouse or sibling of a patient

Criteria

Inclusion Criteria:

  • Indication for brain radiotherapy.
  • Ability to undergo MRI scans and time to participate in neurocognitive testing.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00214175

Locations
United States, Wisconsin
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
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00214175     History of Changes
Other Study ID Numbers: RO04323, NCI-P01 CA88960
Study First Received: September 13, 2005
Last Updated: February 22, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
low grade gliomas and benign CNS lesions

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasms
Glioma
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on May 23, 2013