Recruiting
Phase 2

Radiosurgery

Sponsor:

Jona Hattangadi-Gluth

Code:

NCT04343157

Conditions

Brain Metastases, Adult

Neurocognitive Function

Cancer

Meningioma of Brain

Arteriovenous Malformations, Cerebral

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cognitive Sparing Brain Stereotactic Radiosurgery (SRS)

Study Details

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 for intracranial lesions, 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 patients with intracranial lesions.

Conditions

Brain Metastases, Adult

Neurocognitive Function

Cancer

Meningioma of Brain

Arteriovenous Malformations, Cerebral

Study ID

NCT04343157

Start date

May 1, 2019

Status verified date

Sep, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Image-guided cognitive sparing brain SRS

This is a single arm phase II study where enrolled subjects will receive intracranial SRS will performed identically to standard of care, except for implementing additional imaging techniques and software for additional regional avoidance for cognitive sparing (specifically sparing white matter and the bilateral hippocampus)

Interventions

Cognitive Sparing Brain Stereotactic Radiosurgery (SRS)

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 during SRS for intracranial lesions

Primary outcome measure

  • Change in Verbal Memory from baseline to 3 months after SRS [ Time Frame: Change from Baseline (pre-treatment) to 3 months post treatment ]
  • Change in Executive Functioning from baseline to 3 months after SRS [ Time Frame: Change from Baseline (pre-treatment) to 3 months post treatment ]
  • Change in Attention/Processing Speed from baseline to 3 months after SRS [ Time Frame: Change from Baseline (pre-treatment) to 3 months post treatment ]
  • Change in Language functioning from baseline to 3 months after SRS [ Time Frame: Change from Baseline (pre-treatment) to 3 months post treatment ]

Central Contacts and Locations

Central contacts

Sheila Medina

858-822-6575s4medina@health.ucsd.edu

Locations

Moores Cancer Center

Recruiting

San Diego, California, United States, 92037

Contacts

Sheila Medina

858-822-6575s4medina@health.ucsd.edu

Principal Investigator:

Jona Hattangadi-Gluth, MD

More Information

Sponsor

Jona Hattangadi-Gluth

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jona Hattangadi-Gluth on 2026-09-08.