NCT05755399

Feasibility of Transcranial Focused Ultrasound to Measure Brain Tumor

Recruiting now NA Last updated 2 October 2025

What this trial tests

NA trial testing Brain imaging using transcranial focused ultrasound (tFUS) in Cranial Neurosurgery in 15 participants. Currently enrolling.

Timeline

19 October 2023

Primary endpoint
1 May 2026

30 November 2027

Quick facts

Lead sponsor	University of Minnesota
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	15
Start date	19 October 2023
Primary completion	1 May 2026
Estimated completion	30 November 2027
Sites	1 location across United States

Drugs / interventions tested

• Brain imaging using transcranial focused ultrasound (tFUS)

Conditions studied

• Cranial Neurosurgery — all drugs for Cranial Neurosurgery →

Sponsor

University of Minnesota

Who can join

18 and older, any sex, with Cranial Neurosurgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical Trials of Focused Ultrasound for Brain Tumors.
   Lu VM, Niazi TN. · · 2025 · cited 3× · PMID 39941880 · DOI 10.3390/cancers17030513
2. Regulation of the brain tumor microenvironment by focused ultrasound.
   Fu K, Hu H, Zhou X, Li L, et al · · 2025 · cited 2× · PMID 40520576 · DOI 10.1016/j.omton.2025.200994