UCSD Image-Guided Cognitive-Sparing Radiosurgery for Brain Metastases

NCT04343157 | Recruiting Phase 2

• 2 other identifiers: 170848R01CA238783-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Metastases, Adult; Neurocognitive Function; Cancer

Outcome Measures

Primary Outcomes (4)

• Change in Verbal Memory from baseline to 3 months after SRS

  To evaluate the change from baseline to 3-month post-SRS verbal memory performance when performing relative sparing of eloquent white matter tracts and hippocampi from high doses during brain SRS in patients with 1 to 3 brain metastases. Verbal memory outcomes and measurements include: Hopkins Verbal Learning Test-Revised (HVLT-R)-Immediate, Delayed Recall. Scale of scores is 0-36 for Immediate, 0-12 for Delayed. For both tests, higher scores indicate better performance.

  Change from Baseline (pre-treatment) to 3 months post treatment

• Change in Executive Functioning from baseline to 3 months after SRS

  To evaluate the change from baseline to 3-month post-SRS executive functioning performance when performing relative sparing of eloquent white matter tracts and hippocampi from high doses during brain SRS in patients with 1 to 3 brain metastases. Executive functioning outcomes and measurements include: Controlled Oral Word Association Test (COWA): letter fluency, Trail Making Test Part B (TMT-B). Scale of scores is: Controlled Oral Word Association Test (COWA): letter fluency: 0- no upper limit. Higher score indicates better performance Trail Making Test Part B (TMT-B): 0-240. Higher score indicates poorer performance

  Change from Baseline (pre-treatment) to 3 months post treatment

• Change in Attention/Processing Speed from baseline to 3 months after SRS

  To evaluate the change from baseline to 3-month post-SRS Attention/Processing Speed performance when performing relative sparing of eloquent white matter tracts and hippocampi from high doses during brain SRS in patients with 1 to 3 brain metastases. Attention/Processing Speed outcomes and measurements include: Trail Making Test Part A (TMT-A) Scale of scores is: Trail Making Test Part A (TMT-A): 0-240. Higher score indicates poorer performance

  Change from Baseline (pre-treatment) to 3 months post treatment

• Change in Language functioning from baseline to 3 months after SRS

  To evaluate the change from baseline to 3-month post-SRS Language performance when performing relative sparing of eloquent white matter tracts and hippocampi from high doses during brain SRS in patients with 1 to 3 brain metastases. Language outcomes and measurements include: Boston Naming Test (BNT), Controlled Oral Word Association Test (COWA): category fluency Scale of scores is: Boston Naming Test (BNT): 0-60 Controlled Oral Word Association Test (COWA): category fluency: 0-no upper limit For both tests, higher score indicates better performance.

  Change from Baseline (pre-treatment) to 3 months post treatment

Secondary Outcomes (3)

• Longitudinal changes in imaging biomarker fractional anisotropy (FA) from DTI imaging

  baseline (pre-treatment), 3 months and 6 months post-treatment

• Longitudinal changes in imaging biomarker mean diffusivity (MD) from DTI imaging

  baseline (pre-treatment), 3 months and 6 months post-treatment

• Longitudinal changes in imaging biomarker volume from volumetric MR imaging

  baseline (pre-treatment), 3 months and 6 months post-treatment

Study Arms (1)

Image-guided cognitive sparing brain SRS

EXPERIMENTAL

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)

Radiation: Cognitive Sparing Brain Stereotactic Radiosurgery (SRS)

Interventions

Cognitive Sparing Brain Stereotactic Radiosurgery (SRS) RADIATION

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.

Image-guided cognitive sparing brain SRS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jona Hattangadi-Gluth: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Moores Cancer Center

San Diego, California, 92037, United States

RECRUITING

Related Publications (40)

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Related Links

• A Phase II Randomized Trial of Proton vs. Photon Therapy (IMRT) for Cognitive Preservation in Patients with IDH Mutant, Low to Intermediate Grade Gliomas.
• A Randomized Phase III Trial of Memantine and Whole-Brain Radiotherapy With or Without Hippocampal Avoidance in Patients With Brain Metastases.

MeSH Terms

Conditions

Brain Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jona Hattangadi-Gluth, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheila Medina

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Clinical Professor

Model Details: Study patients will undergo MR imaging with DTI and 3D volumetric imaging at baseline (pre-SRS), and 1 month, 3 months, and 6 months afterwards. This regimen of post-SRS MR imaging is clinical standard of care. Segmentation of critical white matter and hippocampal volumes will be performed pre-SRS for use in brain SRS planning. Formal neurocognitive assessments will be performed at baseline and 3 months post-SRS.

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: April 13, 2020
• Study Start: May 1, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)