Clinical trial NCT01988675: MRI Study of Radiation-Induced Damage to White Matter and Blood-Brain-Barrier
Official title: MRI Study of Radiation-Induced Damage to White Matter and Blood-Brain-Barrier
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Neoplasms
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2013-11-20
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving partial or whole brain radiation therapy

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Change in Magnetic Resonance Imagining (MRI) with different radiation dose at different timepoints.
timeFrame: 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 outcomes:
measure: Associate changes in Magnetic Resonance Imagining (MRI) assessments with changes in neurocognitive function and clinical symptoms, from baseline, and at different timepoints.
timeFrame: 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)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Hosptial
state: Michigan
Study officials:
affiliation: University of Michigan
name: Yue Cao, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: