NCT05755399 Feasibility of Transcranial Focused Ultrasound to Measure Brain Tumor
| NCT ID | NCT05755399 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Minnesota |
| Condition | Cranial Neurosurgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2023-10-19 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2023-10-19 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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)
Contact & Investigator
David Darrow, MD
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT05755399 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cranial Neurosurgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05755399 currently recruiting?
Yes, NCT05755399 is actively recruiting participants. Contact the research team at darro015@umn.edu for enrollment information.
Where is the NCT05755399 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT05755399 clinical trial?
NCT05755399 is sponsored by University of Minnesota. The principal investigator is David Darrow, MD at University of Minnesota. The trial plans to enroll 15 participants.