Recruiting

Transcranial Focused Ultrasound

Sponsor:

University of Minnesota

Code:

NCT05755399

Conditions

Cranial Neurosurgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Brain imaging using transcranial focused ultrasound (tFUS)

Study Details

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 ID

NCT05755399

Start date

Oct 19, 2023

Status verified date

May, 2026

Completion date

Nov 30, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Experimental group

Participants scheduled for brain surgery

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.

Primary outcome measure

  • Test feasibility [ Time Frame: baseline ]

Central Contacts and Locations

Central contacts

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55414

Contacts

More Information

Sponsor

University of Minnesota

Last update posted

May 19, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-05-19.