Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| HUM00040138 | Other Identifier | University of Michigan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
| |
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole Brain Irradiation | Radiation |
| ||
| Partial Brain Irradiation |
| 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) |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients receiving partial or whole brain radiation therapy
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yue Cao, Ph.D. | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Hosptial | Ann Arbor | Michigan | 48109 | United States |
Not provided
Not provided
Not provided
Not provided
| Radiation |
|
| Neuropsychological Testing | Behavioral |
|
| Quality of Life Questionnaire | Behavioral |
|
| Magnetic Resonance Imaging (MRI) Assessments | Device | MRI Assessments include Diffusion Tensor Imaging (DTI)and Gd-DTPA (Diethylenetriamine Pentaacetic Acid - a radioactive tracer injected into the patient and viewed on images). |
|
| 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) |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D009483 | Neuropsychological Tests |
| D008279 | Magnetic Resonance Imaging |
| D010808 | Physical Examination |
| ID | Term |
|---|---|
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided