Feasibility of Transcranial Focused Ultrasound to Measure Brain Tumor

Not Applicable

Recruiting

• Conditions: Cranial Neurosurgery
• Interventions: Device: Brain imaging using transcranial focused ultrasound (tFUS)

• Registration Number: NCT05755399
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-16
• Study First Submitted QC: 2023-02-22
• Study First Posted: 2023-03-06
• Study Start: 2023-10-19
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-22
• Primary Completion: 2025-12-31
• Study Completion: 2027-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group	Brain imaging using transcranial focused ultrasound (tFUS)	Participants scheduled for brain surgery

Primary Outcome Measures

Name	Time	Method
Test feasibility	baseline	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.

Secondary Outcome Measures

Name	Time	Method
Volume assessment	Baseline	three-dimensional reconstructions of MRI slices will be manually segmented, resulting in a tumor volume that will be compared with MRI-segmented tumor volume.
Morphology assessment	Baseline	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.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States