MRI Study of Radiation-Induced Damage to White Matter and Blood-Brain-Barrier
NCT ID: NCT01988675
Last Updated: 2018-06-06
Study Results
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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COMPLETED
91 participants
OBSERVATIONAL
2004-08-26
2014-06-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Partial Brain Irradiation
Patients will receive partial brain irradiation for malignant or benign brain tumors as standard of care. Patients will also have MRI (Magnetic Resonance Imaging) scans and neuropsychological/QOL (Quality of Life Questionnaire) tests prior during and after RT (Radiation Therapy).
Partial Brain Irradiation
Neuropsychological Testing
Quality of Life Questionnaire
Magnetic Resonance Imaging (MRI) Assessments
MRI Assessments include Diffusion Tensor Imaging (DTI)and Gd-DTPA (Diethylenetriamine Pentaacetic Acid - a radioactive tracer injected into the patient and viewed on images).
Whole Brain Irradiation
Patients will receive whole brain irradiation for brain metastases as standard of care. Patients will also have MRI (Magnetic Resonance Imaging) scans and neuropsychological/QOL (Quality of Life Questionnaire) tests prior during and after RT (Radiation Therapy).
Whole Brain Irradiation
Neuropsychological Testing
Quality of Life Questionnaire
Magnetic Resonance Imaging (MRI) Assessments
MRI Assessments include Diffusion Tensor Imaging (DTI)and Gd-DTPA (Diethylenetriamine Pentaacetic Acid - a radioactive tracer injected into the patient and viewed on images).
Interventions
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Whole Brain Irradiation
Partial Brain Irradiation
Neuropsychological Testing
Quality of Life Questionnaire
Magnetic Resonance Imaging (MRI) Assessments
MRI Assessments include Diffusion Tensor Imaging (DTI)and Gd-DTPA (Diethylenetriamine Pentaacetic Acid - a radioactive tracer injected into the patient and viewed on images).
Eligibility Criteria
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Inclusion Criteria
* Patients must be 18 years of age or older
* Patients must sign a study specific consent form approved by the Institutional Review Board (IRB) of the University of Michigan prior to study entry.
* Patients must have a neurological function class 1 or 2 with a Karnofsky performance status (a scoring system used to quantify general well being and quality of life on a scale of 100 to 0) of greater than or equal to 70.
* Patients must have an expected life expectancy of greater than 6 months.
Exclusion Criteria
* Patients who have had prior external beam irradiation to the brain or head/neck area that will lead to overlap of the radiation field.
* Patients should have no contraindications to having a contrast enhanced Magnetic Resonance Imaging (MRI) scan.
* Prisoners are excluded.
* Pregnant women are excluded.
18 Years
ALL
No
Sponsors
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University of Michigan Rogel Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Yue Cao, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan Hosptial
Ann Arbor, Michigan, United States
Countries
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Other Identifiers
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HUM00040138
Identifier Type: OTHER
Identifier Source: secondary_id
UMCC 2003.083
Identifier Type: -
Identifier Source: org_study_id
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