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 volunteersQualifiers
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
Single group
Treatments tested in this trial
Cognitive Sparing Brain Stereotactic Radiosurgery (SRS)
RadiationIn 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
Trial outcomes
Primary outcomes
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 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 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 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.
Secondary outcomes
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
Longitudinal changes in imaging biomarker mean diffusivity (MD) from DTI imaging
To measure longitudinal changes in MD (mm squared/second) from DTI imaging
Longitudinal changes in imaging biomarker volume from volumetric MR imaging
To measure longitudinal changes in volume (cc) from volumetric MR imaging
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