NCT04343157 UCSD Image-Guided Cognitive-Sparing Radiosurgery for Brain Metastases
| NCT ID | NCT04343157 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Jona Hattangadi-Gluth |
| Condition | Brain Metastases, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2019-05-01 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2019-05-01 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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)
Contact & Investigator
Jona Hattangadi-Gluth, MD
PRINCIPAL INVESTIGATOR
University of California, San Diego
Frequently Asked Questions
Who can join the NCT04343157 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Brain Metastases, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04343157 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04343157 currently recruiting?
Yes, NCT04343157 is actively recruiting participants. Contact the research team at s4medina@health.ucsd.edu for enrollment information.
Where is the NCT04343157 trial being conducted?
This trial is being conducted at San Diego, United States.
Who is sponsoring the NCT04343157 clinical trial?
NCT04343157 is sponsored by Jona Hattangadi-Gluth. The principal investigator is Jona Hattangadi-Gluth, MD at University of California, San Diego. The trial plans to enroll 60 participants.