MRI Study of Radiation-Induced Damage to White Matter and Blood-Brain-Barrier

Study Overview
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Brief Summary
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This is a study to determine if Magnetic Resonance Imaging (MRI) techniques can detect early changes in white matter (in the brain) and the blood-brain barrier resulting from radiation therapy.

Detailed Description
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Patients will be assigned to one of two groups based on the type of radiation they will be receiving: whole brain irradiation or partial brain irradiation. Patients will undergo Magnetic Resonance Imaging (MRI) assessments, neurocognitive testing (Quality of Life and Neuropsychological assessments), and clinical evaluation.

Official Title
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MRI Study of Radiation-Induced Damage to White Matter and Blood-Brain-Barrier

Conditions
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Brain Neoplasms

Intervention / Treatment
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* Radiation: Whole Brain Irradiation
* Radiation: Partial Brain Irradiation
* Behavioral: Neuropsychological Testing
* Behavioral: Quality of Life Questionnaire
* Device: Magnetic Resonance Imaging (MRI) Assessments


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients receiving partial brain irradiation for malignant or benign brain tumors (including low-grade gliomas, high-grade gliomas, malignant meningioma, pituitary adenomas, supratentorial meningioma, or craniopharyngiomas); or patients receiving whole brain irradiation for brain metastases. 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 with a history of major medical illness or psychiatric impairment which, in the investigator's opinion, will prevent administration of the protocol. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Partial Brain Irradiation<br>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). | Radiation: Partial Brain Irradiation<br> <br> Behavioral: Neuropsychological Testing<br> <br> Behavioral: Quality of Life Questionnaire<br> <br> Device: Magnetic Resonance Imaging (MRI) Assessments<br>* MRI Assessments include Diffusion Tensor Imaging (DTI)and Gd-DTPA (Diethylenetriamine Pentaacetic Acid - a radioactive tracer injected into the patient and viewed on images).<br>|
| Whole Brain Irradiation<br>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). | Radiation: Whole Brain Irradiation<br> <br> Behavioral: Neuropsychological Testing<br> <br> Behavioral: Quality of Life Questionnaire<br> <br> Device: Magnetic Resonance Imaging (MRI) Assessments<br>* MRI Assessments include Diffusion Tensor Imaging (DTI)and Gd-DTPA (Diethylenetriamine Pentaacetic Acid - a radioactive tracer injected into the patient and viewed on images).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Magnetic Resonance Imagining (MRI) with different radiation dose at different timepoints. | Linear mixed models will be used to relate Magnetic Resonance Imagining (MRI) changes and radiation dose. | Baseline, at 3 weeks on radiation therapy (RT) (partial brain irradiation only), last week of RT, 6 weeks post RT, 4 months post RT (whole brain irradiation only), 6 months post RT, 18 months post RT (partial brain irradiation only) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Associate changes in Magnetic Resonance Imagining (MRI) assessments with changes in neurocognitive function and clinical symptoms, from baseline, and at different timepoints. | Changes in Magnetic Resonance Imagining (MRI) assessments will be compared graphically to changes in neurocognitive function and clinical symptoms. Parallel analysis will be conducted on each of the neurocognitive tests to determine if MRI assessments can identify patients at increased risk for later neurocognitive dysfunction. | Baseline, 6 weeks post radiation therapy (RT), 4 months post RT (whole brain irradiation only), 6 months post RT, 18 months post RT (partial brain irradiation only) |