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

NCT04073966 | Recruiting

• 1 other identifier: LCCC 1844
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Metastases; Neurocognitive Deficit; White Matter Alterations; Radiation Exposure

Outcome Measures

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

  One year after SRS completion

Secondary Outcomes (2)

• Changes in Functional Connectivity

  One year after SRS completion

• Neurocognitive Changes

  One year after SRS completion

Other Outcomes (1)

• Association between Changes in Functional Connectivity and Neurocognitive Changes

  One year after SRS completion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with newly diagnosed brain metastasis being treated with SRS.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

University of North Carolina at Chapel Hill, Department of Radiation Oncology

Chapel Hill, North Carolina, 27599, United States

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms; Leukoaraiosis

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Colette J Shen, MD, PhD

  University of North Carolina at Chapel Hill, Department of Radiation Oncology

  PRINCIPAL INVESTIGATOR

• Tong Zhu, PhD, DABR

  University of North Carolina at Chapel Hill, Department of Radiation Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Becky Green

CONTACT

9849748440; rlgreen@med.unc.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: August 29, 2019
• Study Start: December 4, 2019
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

US (1)