This trial studies how well advanced brain imaging such as blood oxygen level-dependent (BOLD)-function magnetic resonance imaging (fMRI) and diffusion tensor imaging (DTI) can be incorporated into the planning of intracranial stereotactic radiosurgery (SRS) in helping spare cognitive effects in patients with brain lesions. Intracranial SRS uses high, ablative doses of radiotherapy directed at the tumor or lesion, with no regard for critical white matter or cortical structures. Diagnostic procedures such as BOLD-fMRI looks at how the brain processes different types of information, such as movement, language, and memory (cognitive processes). Using BOLD-fMRI and DTI to plan SRS may spare critical brain regions and structures from high doses of radiation, which may reduce the cognitive effects of radiation injury in many patients with brain lesions.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04343157.
Locations matching your search criteria
United States
California
San Diego
UC San Diego Medical Center - HillcrestStatus: Active
Contact: Jona A. Hattangadi-Gluth
Phone: 858-822-6040
PRIMARY OBJECTIVES:
I. To evaluate whether the incorporation of BOLD-fMRI and DTI data into SRS planning can be used to spare eloquent brain regions (i.e., areas involved in language, memory, vision) from high doses of radiation in patients with brain lesions.
EXPLORATORY OBJECTIVES:
I. To determine whether sparing eloquent brain regions in intracranial SRS results in improved cognitive outcomes (i.e., minimal or no decline from baseline to 3-months and 6-months post SRS) relative to historic controls from randomized data.
II. To measure the association of radiation dose and change in imaging biomarkers on brain magnetic resonance imaging (MRI) (white matter, hippocampal, cortical changes) and association of these biomarkers with cognitive changes in patients undergoing intracranial SRS.
OUTLINE:
Patients undergo a developmental neuropsychological assessment over 45 minutes before SRS, and at 3 and 6 months. Patients also undergo BOLD fMRI and DTI over 30-60 minutes prior to undergoing intracranial SRS.
After completion of study treatment, participants are followed up every 2-3 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUC San Diego Medical Center - Hillcrest
Principal InvestigatorJona A. Hattangadi-Gluth
