Status:
RECRUITING
UCSD Image-Guided Cognitive-Sparing Radiosurgery for Brain Metastases
Lead Sponsor:
Jona Hattangadi-Gluth
Collaborating Sponsors:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Conditions:
Brain Metastases, Adult
Neurocognitive Function
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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, incor...
Detailed Description
Background: Brain metastases affect one third of adult cancer patients. Stereotactic radiosurgery (SRS) is standard of care for patients with limited brain metastases. Yet most patients will experienc...
Eligibility Criteria
Inclusion
- 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
- Able to give informed consent
Exclusion
- Pregnant or nursing women
- 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)
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04343157
Start Date
May 1 2019
End Date
December 31 2024
Last Update
June 18 2024
Active Locations (1)
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1
Moores Cancer Center
San Diego, California, United States, 92037