Feasibility of Transcranial Focused Ultrasound to Measure Brain Tumor

University of Minnesota (UMN)

Status: Enrolling

Conditions: Cranial Neurosurgery

Treatments: Device: Brain imaging using transcranial focused ultrasound (tFUS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05755399

Feasibility

Details and patient eligibility

About

Transcranial focused ultrasound (tFUS) offers a platform for non-invasive imaging and treatment of the brain and pathology of the brain -- allowing high resolution imaging in both spatial and temporal dimensions. Compared with the gold- standard for brain imaging, magnetic resonance imaging (MRI), ultrasound offers reduced contrast while providing improved sampling in time through a significantly more cost-effective approach. In addition, while MRI is used to guide invasive treatments, only ultrasound can offer treatments through three primary mechanisms: 1) neuromodulation, 2) blood brain barrier modulation, and thermal/mechanical ablation through high intensity focused ultrasound (HIFU). All three treatment options require targeting therapy through the skull, which remains a barrier to clinical translation. This proposal is to test the feasibility of acquiring noninvasive targeting imaging intraoperatively prior to clinically indicated cranial neurosurgery. By acquiring volumetric ultrasound images while coregistered to previously obtained stereotactic magnetic resonance imaging, the study will be able to compare the ability of tFUS to identify and focus on brain pathology.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able to undergo informed consent
• Scheduled and present for brain surgery
• General Anesthesia planned
• Neuronavigation used for surgery
• Thin cut post-contrast imaging available for coregistration
• At least 18 years of age

Exclusion criteria

• Awake craniotomy planned
• Unhealed wounds or infection of scalp
• Diseases and conditions that would increase the morbidity and mortality of craniotomy and tumor resection (e.g. cardiopulmonary issues) in the opinion of the PI.
• Pregnancy (also generally required for surgery)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Experimental group

Experimental group

Description:

Participants scheduled for brain surgery

Treatment:

Device: Brain imaging using transcranial focused ultrasound (tFUS)