Cognitive-sparing radiosurgery for brain metastases
UCSD Image-Guided Cognitive-Sparing Radiosurgery for Brain Metastases: Avoidance of Eloquent White Matter and Hippocampal Regions
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 |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT04343157 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with tumors invading critical brain areas or those unable to undergo MRI scans may not benefit from this study.
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 performed: While cognitive-sparing approaches in radiosurgery are being explored, this study employs novel imaging techniques, making it a potentially unique contribution to the field.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients 18 years or older 2. One to three brain metastases targets, all smaller than 3 cm in diameter (intact or resected tumor bed) 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 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 this trial is running
San Diego, California
- 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
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.