Feasibility of Transcranial Focused Ultrasound to Measure Brain Tumor

NCT05755399 | Recruiting FDA Device

• 1 other identifier: Feasibility
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cranial Neurosurgery

Outcome Measures

Primary Outcomes (1)

• Test feasibility

  For each participant feasibility is defined as 1 when any ultrasound slices are obtained and segmented. If tumor segmentation cannot be performed then this will be reported as 0, meaning not feasible. The result at the group level is a feasibility measure, i.e., the proportion of participants for whom the protocol was feasible.

  baseline

Secondary Outcomes (2)

• Volume assessment

  Baseline

• Morphology assessment

  Baseline

Study Arms (1)

Experimental group

EXPERIMENTAL

Participants scheduled for brain surgery

Device: Brain imaging using transcranial focused ultrasound (tFUS)

Interventions

Brain imaging using transcranial focused ultrasound (tFUS) DEVICE

All enrolled patients will be imaged using the MRI as standard of care. The patient will additionally be imaged using the tFUS system, ICC HIFU Synthesizer. Total imaging time will be limited to 15 minutes. Following image acquisition by the ultrasound, the standard of care surgery will be performed.

Experimental group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

RECRUITING

Study Officials

• David Darrow, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Darrow, MD

CONTACT

612-624-6666; darro015@umn.edu

Crina Peterson

CONTACT

612-624-6666; pet04139@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: March 6, 2023
• Study Start: October 19, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)