UCSD Image-Guided Cognitive-Sparing Radiosurgery for Brain Metastases
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.
Conditions:
🦠 Brain Metastases, Adult 🦠 Neurocognitive Function 🦠 Cancer
🗓️ Study Start (Actual) 1 May 2019
🗓️ Primary Completion (Estimated) 31 December 2024
✅ Study Completion (Estimated) 31 December 2024
👥 Enrollment (Estimated) 60
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 San Diego, California, United States

📋 Eligibility Criteria

Description

    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)
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 2 August 2019
  • First Submitted that Met QC Criteria 8 April 2020
  • First Posted 13 April 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 14 June 2024
  • Last Update Posted 18 June 2024
  • Last Verified June 2024