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

This study has been completed.
Sponsor:
Collaborator:
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

September 13, 2005
February 22, 2012
June 2004
January 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00214175 on ClinicalTrials.gov Archive Site
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Determination of Fraction Size Equivalent Dose (FED) Levels for Intracranial Conformal Avoidance Radiotherapy
Determination of Fraction Size Equivalent Dose (FED) Levels for Intracranial Conformal Avoidance Radiotherapy

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.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

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

  • Glioma
  • Brain Neoplasms
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  • patients
    patients who will receive XRT
  • matched volunteers
    Spouse or sibling
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
January 2011
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Indication for brain radiotherapy.
  • Ability to undergo MRI scans and time to participate in neurocognitive testing.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00214175
RO04323, NCI-P01 CA88960
No
University of Wisconsin, Madison
University of Wisconsin, Madison
National Cancer Institute (NCI)
Principal Investigator: Wolfgang Tome, PhD University of Wisconsin, Madison
University of Wisconsin, Madison
February 2012

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