Cognitive-sparing radiosurgery for brain metastases
Official title: UCSD Image-Guided Cognitive-Sparing Radiosurgery for Intracranial Lesions: Avoidance of Eloquent White Matter and Hippocampal Regions
Run by University of California, San Diego · NCT04343157 · Data updated 2026-11-12
This study is testing a new way to use targeted radiation for patients with brain tumors to see if it can help protect their thinking skills while treating the cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | University of California, San Diego Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (San Diego, California) |
| Status | Recruiting |
| Started | May 1, 2019 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | September 8, 2026 |
| Trial ID | NCT04343157 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with 1 to 3 brain metastases smaller than 3 cm and an ECOG performance status of 0-2.
✕Probably not a fit
Patients with tumors invading critical brain areas or those unable to undergo MRI scans 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 clinical trial investigates the use of advanced imaging techniques to guide stereotactic radiosurgery (SRS) in patients with brain metastases, aiming to minimize cognitive decline post-treatment. The study employs diffusion tensor imaging (DTI) and volumetric imaging to identify and protect critical brain regions during SRS. By evaluating cognitive performance and measuring changes in brain structure over time, the trial seeks to enhance patient outcomes and preserve neurocognitive function. Participants will be monitored for cognitive changes and imaging biomarkers following treatment.
Why it matters
Potential benefit: If successful, this approach could significantly reduce cognitive decline in patients undergoing treatment for brain metastases.
How similar studies have gone: While cognitive-sparing approaches in radiosurgery are being explored, this study employs novel imaging techniques, making it a potentially unique contribution to the field.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients 18 years or older 2. Eligible for intracranial SRS: Limited brain metastases targets geometrically feasible for SRS (intact or resected tumor bed), meningioma, or cerebral AVM 3. 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) 4. Ability to answer questions and follow commands via neurocognitive testing 5. Estimated life expectancy greater than 6 months 6. Pathologic confirmation of extracerebral tumor site (eg, lung, breast, prostate) from either the primary site or a metastatic lesion if brain metastasis 7. Willingness/Ability to undergo brain MRI scans 8. Able to give informed consent Exclusion Criteria: 1. Pregnant or nursing women 2. Women of childbearing potential unwilling to use adequate contraception 3. Inability to complete a magnetic resonance imaging scan with contrast 4. 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) 5. Planned chemotherapy during SRS (on the day of SRS) 6. Previous whole brain radiation therapy 7. Leptomeningeal metastases (ineligible for SRS) 8. Metastases from primary germ cell tumor, small cell carcinoma, or primary CNS lymphoma (ineligible for SRS)
Where it's running
-
Moores Cancer Center
San Diego, California, United States Recruiting
Study contacts
- Principal investigator: Jona Hattangadi-Gluth, MD — University of California, San Diego
- Study coordinator: Sheila Medina
- Email: s4medina@health.ucsd.edu
- Phone: 858-822-6575
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.