Understanding brain changes after radiation treatment for brain metastases
Magnetic Resonance Imaging Biomarkers for Radiation-Induced Neurocognitive Decline Following Stereotactic Radiosurgery of Newly Diagnosed Brain Metastases: An Observational Pilot Study
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 type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT04073966 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While there is ongoing research in this area, this specific approach focusing on MRI biomarkers and neurocognitive decline following SRS is relatively novel.
Eligibility criteria
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 this trial is running
Chapel Hill, North Carolina
- 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: Becky Green
- Email: rlgreen@med.unc.edu
- Phone: 9849748440
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.