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

University of Michigan Rogel Cancer Center

Status: Completed

Conditions: Brain Neoplasms

Treatments: Device: Magnetic Resonance Imaging (MRI) Assessments; Behavioral: Neuropsychological Testing; Radiation: Partial Brain Irradiation; Behavioral: Quality of Life Questionnaire; Radiation: Whole Brain Irradiation

Study type: Observational

Funder types: Other

Identifiers

NCT01988675

UMCC 2003.083

HUM00040138 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 91 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

91 participants in 2 patient groups

Partial Brain Irradiation

Description:

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).

Treatment:

Device: Magnetic Resonance Imaging (MRI) Assessments

Behavioral: Neuropsychological Testing

Radiation: Partial Brain Irradiation

Behavioral: Quality of Life Questionnaire

Whole Brain Irradiation

Description:

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).

Treatment:

Device: Magnetic Resonance Imaging (MRI) Assessments

Behavioral: Neuropsychological Testing

Radiation: Whole Brain Irradiation

Behavioral: Quality of Life Questionnaire