MRI Biomarkers for Radiation-Induced Neurocognitive Decline Following SRS of Newly Diagnosed Brain Mets

Brain Metastases Clinical Trial

Official title:

Magnetic Resonance Imaging Biomarkers for Radiation-Induced Neurocognitive Decline Following Stereotactic Radiosurgery of Newly Diagnosed Brain Metastases: An Observational Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04073966
• Other study ID #: LCCC 1844
• Status: Recruiting
• Start date: December 4, 2019
• Est. completion date: September 15, 2026

Study information

• Verified date: January 2024
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: Becky Green
• Phone: 9849748440
• Email: rlgreen[@]med.unc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 15, 2026
• Est. primary completion date: September 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Leukoaraiosis
• Neoplasm Metastasis
• Neurocognitive Deficit
• Radiation Exposure
• White Matter Alterations

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill, Department of Radiation Oncology	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Association between Changes in Functional Connectivity and Neurocognitive Changes	Correlation between magnitude of neurocognitive function decline and severity of radiation-induced brain injury	One year after SRS completion
Primary	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	One year after SRS completion
Secondary	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	One year after SRS completion
Secondary	Neurocognitive Changes	Change in neurocognitive function, as measured by Delis-Kaplan testing, after SRS treatment	One year after SRS completion