RecruitingNot ApplicableNCT05755399

Feasibility of Transcranial Focused Ultrasound to Measure Brain Tumor


Sponsor

University of Minnesota

Enrollment

15 participants

Start Date

Oct 19, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether transcranial focused ultrasound — sound waves aimed at the skull — can measure brain tumor characteristics during surgery, potentially offering surgeons real-time information to improve how much tumor they can safely remove. **You may be eligible if...** - You are 18 or older - You are scheduled for brain tumor surgery at the participating center - You will be under general anesthesia during the procedure - Your surgery will use neuronavigation (a GPS-like system for the brain) - High-resolution contrast imaging of your brain is available **You may NOT be eligible if...** - You are having an awake craniotomy - You have an unhealed scalp wound or active scalp infection - You have heart or lung conditions that significantly increase the risk of brain surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBrain 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.


Locations(1)

University of Minnesota

Minneapolis, Minnesota, United States

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NCT05755399


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