Status:
RECRUITING
MRI Biomarkers for Radiation-Induced Neurocognitive Decline Following SRS of Newly Diagnosed Brain Mets
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Conditions:
Brain Metastases
Neurocognitive Deficit
Eligibility:
All Genders
18+ years
Brief Summary
Brain metastases are a source of much morbidity and mortality in adults with primary solid malignant tumors. With improvements in systemic therapy that prolong survival but have limited central nervou...
Detailed Description
The proposed study aims to provide novel and useful information for clinicians, both to help predict potential neurocognitive changes following SRS, and as a possible guide for SRS treatment alteratio...
Eligibility Criteria
Inclusion
- Histologic diagnosis of cancer
- Newly diagnosed brain metastasis being treated with SRS. Any extent of cranial disease permitted. Subsequent courses of SRS while on study permitted when clinically indicated.
- Patients are permitted to have undergone craniotomy and resection of metastasis/metastases if at least 1 other intact metastasis planned for definitive SRS is present. Receiving or previously received systemic therapy also permitted.
- Anticipated life expectancy at least 1 year
- Age ≥ 18 years
- Ability to read and comprehend written English and follow instructions in English
- Ability to provide informed consent
Exclusion
- Previous radiation to the brain or head
- Previous malignancy - other than non-melanomatous skin cancer or cervical carcinoma in situ - and not disease-free for at least 3 years
- Previous severe head or brain injury
- History of a neurological disorder such as Epilepsy, Parkinson's, Alzheimer's, or Dementia
- Prisoners
Key Trial Info
Start Date :
December 4 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 15 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04073966
Start Date
December 4 2019
End Date
September 15 2026
Last Update
September 19 2025
Active Locations (1)
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1
University of North Carolina at Chapel Hill, Department of Radiation Oncology
Chapel Hill, North Carolina, United States, 27599