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

NCT00214175 | Completed

• 2 other identifiers: RO04323NCI-P01 CA88960
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioma; Brain Neoplasms

Keywords

low grade gliomas and benign CNS lesions

Study Arms (2)

patients

patients who will receive XRT

matched volunteers

Spouse or sibling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Indication for brain radiotherapy.
• Ability to undergo MRI scans and time to participate in neurocognitive testing.

Sponsors & Collaborators

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

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Glioma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Wolfgang Tome, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: June 1, 2004
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: February 24, 2012

Record last verified: 2012-02

Locations

US (1)