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NCT05755399 · ClinicalTrials.gov registry record · NA

Feasibility of Transcranial Focused Ultrasound to Measure Brain Tumor

A NA study of Cranial Neurosurgery, sponsored by University of Minnesota.

Recruiting
Registry status
NA
Development phase
15
Enrollment target
1
Study location

NCT05755399: Recruiting NA study of Cranial Neurosurgery, sponsored by University of Minnesota.

NCT05755399 is a NA study of Cranial Neurosurgery that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 15 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05755399, a NA study of Cranial Neurosurgery, is actively recruiting participants, sponsored by University of Minnesota.

RECRUITING
Registry status
NA
Development phase
15 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

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.

Conditions Studied

Interventions

  • DEVICE Brain imaging using transcranial focused ultrasound (tFUS)

Study Locations (1)

Minnesota

  • University of Minnesota - Minneapolis

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2023-10-19
Est. Completion 2027-11-30
Phase NA
University of Minnesota

966 total trials

What NCT05755399 shows while recruiting

NCT05755399 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 1 condition, with Cranial Neurosurgery appearing as the primary indexed condition, and to 1 intervention - of which Brain imaging using transcranial focused ultrasound (tFUS) is the first listed.

NCT05755399 reports a single indexed study location in Minnesota.

Frequently Asked Questions

What is clinical trial NCT05755399 about?

NCT05755399 is a clinical study titled "Feasibility of Transcranial Focused Ultrasound to Measure Brain Tumor". 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), u...

What is the current status of trial NCT05755399?

This trial is currently recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2023-10-19. Estimated completion is 2027-11-30.

What conditions does trial NCT05755399 study?

This clinical trial studies the following conditions: Cranial Neurosurgery.

What interventions are being tested in trial NCT05755399?

The interventions under investigation include: Brain imaging using transcranial focused ultrasound (tFUS) (DEVICE).

Who is sponsoring clinical trial NCT05755399?

This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05755399 being conducted?

This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT05755399's enrollment target sits among peer trials

15 1881st of 2000 higher than 92 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05755399, the US trial registry maintained by the National Library of Medicine. NCT05755399 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.