NCT04073966 MRI Biomarkers for Radiation-Induced Neurocognitive Decline Following SRS of Newly Diagnosed Brain Mets
| NCT ID | NCT04073966 |
| Status | Recruiting |
| Phase | — |
| Sponsor | UNC Lineberger Comprehensive Cancer Center |
| Condition | Brain Metastases |
| Study Type | OBSERVATIONAL |
| Enrollment | 15 participants |
| Start Date | 2019-12-04 |
| Primary Completion | 2026-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 15 participants in total. It began in 2019-12-04 with a primary completion date of 2026-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 nervous system penetration, patients with brain metastases are at increasing risk of developing and experiencing long-term side effects from treatment of brain metastases. The overarching goal of this study is to better understand the determinants of RT-associated changes in white and gray matter function and associated neurocognitive decline.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Colette J Shen, MD, PhD
PRINCIPAL INVESTIGATOR
University of North Carolina at Chapel Hill, Department of Radiation Oncology
Frequently Asked Questions
Who can join the NCT04073966 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Brain Metastases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04073966 currently recruiting?
Yes, NCT04073966 is actively recruiting participants. Contact the research team at rlgreen@med.unc.edu for enrollment information.
Where is the NCT04073966 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT04073966 clinical trial?
NCT04073966 is sponsored by UNC Lineberger Comprehensive Cancer Center. The principal investigator is Colette J Shen, MD, PhD at University of North Carolina at Chapel Hill, Department of Radiation Oncology. The trial plans to enroll 15 participants.