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

NCT ID: NCT00214175

Last Updated: 2012-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-06-30

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Glioma Brain Neoplasms

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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patients

patients who will receive XRT

No interventions assigned to this group

matched volunteers

Spouse or sibling

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Indication for brain radiotherapy.
* Ability to undergo MRI scans and time to participate in neurocognitive testing.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wolfgang Tome, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-P01 CA88960

Identifier Type: -

Identifier Source: secondary_id

RO04323

Identifier Type: -

Identifier Source: org_study_id

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