An observational study in Brain Metastases, Neurocognitive Deficit and White Matter Alterations, sponsored by UNC Lineberger Comprehensive Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by UNC Lineberger Comprehensive Cancer Center · Observational
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.
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 alteration, whether through adjustment of dose or beam arrangements in relation to white matter tracts. In this observational pilot study of 20 patients, the association between RT-associated brain injury and neurocognitive function will be quantitatively assessed longitudinally over one year following SRS. The study team hypothesizes that, over this time, (1) there will be radiation dose-dependent reductions in regional white matter tract integrity and reduction in functional connectivity in the default mode network of gray matter, (2) there will be measurable decline in neurocognitive function, and (3) there will be an association between severity of radiation-induced brain injury on MRI and magnitude of neurocognitive functional decline. This association will relate, in part, to the location(s) affected.
1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.
This study's planned enrollment of 20 is below the median of 100 across 380 observational studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 414 studies on the registry; 96 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 25 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with newly diagnosed brain metastasis being treated with SRS.
Exclusion Criteria:
Radiation-Induced White Matter Injury
Dose-dependent reductions in white matter integrity, as quantified by Diffusion Tensor MRI (DTI)-derived measures of change in diffusivity
Time frame: One year after SRS completion
Changes in Functional Connectivity
Dose-dependent alterations in functional connectivity, especially for the subsystems of the Default Mode Network (DMN), as measured by resting state functional MRI
Time frame: One year after SRS completion
Neurocognitive Changes
Change in neurocognitive function, as measured by Delis-Kaplan testing, after SRS treatment
Time frame: One year after SRS completion
Association between Changes in Functional Connectivity and Neurocognitive Changes
Correlation between magnitude of neurocognitive function decline and severity of radiation-induced brain injury
Time frame: One year after SRS completion
Plan to share: No
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UNC Lineberger Comprehensive Cancer Center