Feasibility of Transcranial Focused Ultrasound to Measure Brain Tumor

Sponsor
University of Minnesota (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05755399
Collaborator
(none)
15
1
1
35.1
0.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Brain imaging using transcranial focused ultrasound (tFUS)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Feasibility of Transcranial Focused Ultrasound to Measure Brain Tumor
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Feb 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental group

Participants scheduled for brain surgery

Device: Brain 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Minnesota Minneapolis Minnesota United States 55414

Sponsors and Collaborators

  • University of Minnesota

Investigators

  • Principal Investigator: David Darrow, MD, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Minnesota
ClinicalTrials.gov Identifier:
NCT05755399
Other Study ID Numbers:
  • Feasibility
First Posted:
Mar 6, 2023
Last Update Posted:
Mar 6, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 6, 2023