UCSD Image-Guided Cognitive-Sparing Radiosurgery for Brain Metastases
United States60 participantsStarted 2019-05-01
Plain-language summary
In this proposal, the investigators introduce advanced diffusion and volumetric imaging techniques along with innovative, automated image parcellation methods to identify critical brain regions, incorporate into cognitive-sparing SRS, and analyze biomarkers of radiation response. This work will advance the investigators' understanding of neurocognitive changes after brain SRS and help create interventions that preserve cognitive-function in brain metastases patients.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients 18 years or older
. One to three brain metastases targets, all smaller than 3 cm in diameter (intact or resected tumor bed)
. Eastern cooperative Oncology Group (ECOG) performance status 0-2 (score of 0, no symptoms; 1, mild symptoms; 2, symptomatic, \<50% in bed during the day)
. Ability to answer questions and follow commands via neurocognitive testing
. Estimated life expectancy greater than 6 months
. Pathologic confirmation of extracerebral tumor site (eg, lung, breast, prostate) from either the primary site or a metastatic lesion
. Willingness/Ability to undergo brain MRI scans
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically trying to preserve memory, attention, and language after radiosurgery for brain metastases — how do my particular tumor locations in the brain affect whether this cognitive-sparing approach might be relevant for my situation?
2Since this is a Phase 2 trial, the researchers are still building evidence on how well this image-guided approach protects brain function — what do we currently know about its safety compared to standard radiosurgery, and what unknowns should I be aware of before considering it?
3The trial measures cognitive changes at 3 months after treatment — if my cognitive function were to decline during that window, what support or follow-up would be available to me, and how would that affect my overall treatment plan?
4Would standard radiosurgery or whole-brain radiation therapy be a reasonable alternative for my case, and is there a meaningful difference in how well each option controls the brain metastases compared to what this trial is testing?
5The trial involves cognitive testing at baseline and again at 3 months — how time-consuming and demanding are those assessments, and is the travel and testing schedule realistic given where I am in my overall cancer treatment?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Verbal Memory from baseline to 3 months after SRS
Timeframe: Change from Baseline (pre-treatment) to 3 months post treatment
2
Change in Executive Functioning from baseline to 3 months after SRS
Timeframe: Change from Baseline (pre-treatment) to 3 months post treatment
3
Change in Attention/Processing Speed from baseline to 3 months after SRS
Timeframe: Change from Baseline (pre-treatment) to 3 months post treatment
4
Change in Language functioning from baseline to 3 months after SRS
Timeframe: Change from Baseline (pre-treatment) to 3 months post treatment
. Women of childbearing potential unwilling to use adequate contraception
. Inability to complete a magnetic resonance imaging scan with contrast
. Tumor directly invading the critical area to be spared (for example a patient with tumor invading a critical white matter tract; ineligible for cognitive-sparing)
. Planned chemotherapy during SRS (on the day of SRS)
. Previous whole brain radiation therapy
. Leptomeningeal metastases (ineligible for SRS)
. Metastases from primary germ cell tumor, small cell carcinoma, or primary CNS lymphoma (ineligible for SRS)