Feasibility of Transcranial Focused Ultrasound to Measure Brain Tumor

NCT ID: NCT05755399

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-19
• Study Completion Date: 2027-11-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Experimental group

Participants scheduled for brain surgery

Group Type: EXPERIMENTAL

Brain imaging using transcranial focused ultrasound (tFUS)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Darrow, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

David Darrow, MD

Role: CONTACT

darro015@umn.edu

612-624-6666

Crina Peterson

Role: CONTACT

pet04139@umn.edu

612-624-6666

Facility Contacts

David Darrow

Role: primary

darro015@umn.edu

612-624-6666

Other Identifiers

Feasibility

Identifier Type: -

Identifier Source: org_study_id