MRI Study of Radiation-Induced Damage to White Matter and Blood-Brain-Barrier
Information source: University of Michigan Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Brain Neoplasms
Intervention: Whole Brain Irradiation (Radiation); Partial Brain Irradiation (Radiation); Neuropsychological Testing (Behavioral); Quality of Life Questionnaire (Behavioral); Magnetic Resonance Imaging (MRI) Assessments (Device)
Phase: N/A
Status: Recruiting
Sponsored by: University of Michigan Cancer Center Official(s) and/or principal investigator(s): Yue Cao, Ph.D., Principal Investigator, Affiliation: University of Michigan
Overall contact: Yue Cao, Ph.D., Phone: 734-936-8695, Email: yuecao@umich.edu
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.
Clinical Details
Official title: MRI Study of Radiation-Induced Damage to White Matter and Blood-Brain-Barrier
Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Primary outcome: Change in Magnetic Resonance Imagining (MRI) with different radiation dose at different timepoints.
Secondary outcome: Associate changes in Magnetic Resonance Imagining (MRI) assessments with changes in neurocognitive function and clinical symptoms, from baseline, and at different timepoints.
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): 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.
Locations and Contacts
Yue Cao, Ph.D., Phone: 734-936-8695, Email: yuecao@umich.edu
University of Michigan Hosptial, Ann Arbor, Michigan 48109, United States; Recruiting Yue Cao, Ph.D., Phone: 734-936-8695, Email: yuecao@umich.edu Yue Cao, Ph.D., Principal Investigator
Additional Information
Starting date: July 2004
Last updated: May 18, 2015
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