MRI Study of Radiation-Induced Damage to White Matter and Blood-Brain-Barrier
Conditions
Brain Neoplasms
Conditions: official terms
Brain Neoplasms
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Intervention
Name: Whole Brain Irradiation Type: Radiation
Name: Partial Brain Irradiation Type: Radiation
Name: Neuropsychological Testing Type: Behavioral
Name: Quality of Life Questionnaire Type: Behavioral
Name: Magnetic Resonance Imaging (MRI) Assessments Type: Device
Overall Status
Recruiting
Summary
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
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
Location
University of Michigan Hosptial
Ann Arbor, Michigan, United States
Status: Recruiting
Contact: Yue Cao, Ph.D. - 734-936-8695 - yuecao@umich.edu
Start Date
July 2004
Sponsors
University of Michigan Cancer Center
Source
University of Michigan Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page