Recruiting

Observational Study

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT04073966

Conditions

Brain Metastases

Neurocognitive Deficit

White Matter Alterations

Radiation Exposure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT04073966

Start date

Dec 4, 2019

Status verified date

Aug, 2026

Completion date

May 31, 2029

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Radiation-Induced White Matter Injury [ Time Frame: One year after SRS completion ]

Central Contacts and Locations

Central contacts

Olivia Morton

9849748440olivia_roberts@med.unc.edu

Locations

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

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Olivia Morton

984-974-8441olivia_roberts@med.unc.edu

Principal Investigator:

Colette J Shen, MD, PhD

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-08-14.