UCSD Image-Guided Cognitive-Sparing Radiosurgery for Intracranial Lesions

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJona Hattangadi-Gluth

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients 18 years or older

Eligible for intracranial SRS: Limited brain metastases targets geometrically feasible for SRS (intact or resected tumor bed), meningioma, or cerebral AVM

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • 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 during SRS for intracranial lesions

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: Image-guided cognitive sparing brain SRSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Change from Baseline (pre-treatment) to 3 months post treatment
2

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

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

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

Time frame
Change from Baseline (pre-treatment) to 3 months post treatment
4

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.

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

Secondary outcomes

1

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

To measure longitudinal changes in FA (unitless index between 0 and 1) from DTI imaging

Time frame
baseline (pre-treatment), 3 months and 6 months post-treatment
2

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

To measure longitudinal changes in MD (mm squared/second) from DTI imaging

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

Longitudinal changes in imaging biomarker volume from volumetric MR imaging

To measure longitudinal changes in volume (cc) from volumetric MR imaging

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jona Hattangadi-Gluth

Lead sponsor

University of California, San Diego

Sponsor institution

National Institutes of Health (NIH)

Collaborator

National Cancer Institute (NCI)

Collaborator