Clinical trial Recruiting at 1 site Observational Ages 18 and up

Understanding brain changes after radiation treatment for brain metastases

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

Run by UNC Lineberger Comprehensive Cancer Center · NCT04073966 · Data updated 2026-11-12

This study is testing how radiation treatment for brain metastases affects thinking and memory over a year to help improve future care for patients.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment20 (estimated)
SponsorUNC Lineberger Comprehensive Cancer Center
Academic / other
Drugs / interventionsradiation
Locations1 site (Chapel Hill, North Carolina)
StatusRecruiting
StartedDecember 4, 2019
Main results expectedMay 31, 2028
Study endsMay 31, 2029
Registry record updatedAugust 14, 2026
Trial IDNCT04073966 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults aged 18 and older with a histologic diagnosis of cancer and newly diagnosed brain metastases being treated with SRS.

Probably not a fit

Patients with a history of previous brain radiation, severe neurological disorders, or those who are prisoners may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational pilot study aims to investigate the effects of stereotactic radiosurgery (SRS) on neurocognitive function in patients with newly diagnosed brain metastases. By assessing MRI biomarkers, the study will evaluate the relationship between radiation-induced brain injury and cognitive decline over one year. The research will focus on how radiation dose impacts white matter integrity and functional connectivity in the brain, providing insights that could inform treatment adjustments. The goal is to enhance understanding of the long-term cognitive effects of radiation therapy in this patient population.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies that minimize cognitive decline in patients undergoing radiation therapy for brain metastases.

How similar studies have gone: While there is ongoing research in this area, this specific approach focusing on MRI biomarkers and neurocognitive decline following SRS is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • University of North Carolina at Chapel Hill, Department of Radiation Oncology
    Chapel Hill, North Carolina, United States
    Recruiting

Study contacts

  • Principal investigator: Colette J Shen, MD, PhD — University of North Carolina at Chapel Hill, Department of Radiation Oncology
  • Study coordinator: Olivia Morton
  • Email: olivia_roberts@med.unc.edu
  • Phone: 9849748440

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.