MRI Biomarkers for Radiation-Induced Neurocognitive Decline Following SRS of Newly Diagnosed Brain Mets
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUNC Lineberger Comprehensive Cancer Center
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients with newly diagnosed brain metastasis being treated with SRS.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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 completionSecondary outcomes
1
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 completion2
Neurocognitive Changes
Change in neurocognitive function, as measured by Delis-Kaplan testing, after SRS treatment
Time frame
One year after SRS completionOther outcomes
1
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 completionSponsors and contacts
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Source ClinicalTrials.gov