Clinical trial · Observational
MRI Study of Radiation-Induced Damage to White Matter and Blood-Brain-Barrier
NCT01988675CI-TRIAL-00033204completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Neoplasms | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Magnetic Resonance Imaging (MRI) Assessments | Device | — | UNRESOLVED |
| Neuropsychological Testing | Behavioral | — | UNRESOLVED |
| Partial Brain Irradiation | Radiation | — | UNRESOLVED |
| Quality of Life Questionnaire | Behavioral | — | UNRESOLVED |
| Whole Brain Irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 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).
- interventionNames
- Radiation: Partial Brain Irradiation
- Behavioral: Neuropsychological Testing
- Behavioral: Quality of Life Questionnaire
- Device: Magnetic Resonance Imaging (MRI) Assessments
- label
- 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).
- interventionNames
- Radiation: Whole Brain Irradiation
- Behavioral: Neuropsychological Testing
- Behavioral: Quality of Life Questionnaire
- Device: Magnetic Resonance Imaging (MRI) Assessments
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.