Feasibility of Transcranial Focused Ultrasound to Measure Brain Tumor

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.

Study Overview

• Status: Recruiting
• Conditions: Cranial Neurosurgery
• Intervention / Treatment: Device: Brain imaging using transcranial focused ultrasound (tFUS)

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Darrow, MD; Phone Number: 612-624-6666; Email: darro015@umn.edu
• Study Contact Backup: Name: Crina Peterson; Phone Number: 612-624-6666; Email: pet04139@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • Recruiting
      • University of Minnesota
      • Contact: David Darrow; Phone Number: 612-624-6666; Email: darro015@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Participants scheduled for brain surgery	Device: Brain imaging using transcranial focused ultrasound (tFUS); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume assessment	three-dimensional reconstructions of MRI slices will be manually segmented, resulting in a tumor volume that will be compared with MRI-segmented tumor volume.	Baseline
Morphology assessment	three-dimensional ultrasound and MRI reconstructions will be co-registered onto a three dimensional grid and compared. The ratio of the MRI and FUS derived volumes will be computed, resulting in a distribution. A value of one for this ratio indicates perfect agreement.	Baseline

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: David Darrow, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: January 16, 2023
• First Submitted That Met QC Criteria: February 22, 2023
• First Posted (Actual): March 6, 2023

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: Feasibility

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes