Feasibility of Transcranial Focused Ultrasound to Measure Brain Tumor
Primary Purpose
Cranial Neurosurgery
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brain imaging using transcranial focused ultrasound (tFUS)
Sponsored by
About this trial
This is an interventional other trial for Cranial Neurosurgery
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)
Sites / Locations
- University of MinnesotaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental group
Arm Description
Participants scheduled for brain surgery
Outcomes
Primary Outcome Measures
Test feasibility
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
Volume assessment
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
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.
Full Information
NCT ID
NCT05755399
First Posted
January 16, 2023
Last Updated
October 23, 2023
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT05755399
Brief Title
Feasibility of Transcranial Focused Ultrasound to Measure Brain Tumor
Official Title
Feasibility of Transcranial Focused Ultrasound to Measure Brain Tumor
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2023 (Actual)
Primary Completion Date
October 19, 2024 (Anticipated)
Study Completion Date
September 19, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cranial Neurosurgery
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Participants scheduled for brain surgery
Intervention Type
Device
Intervention Name(s)
Brain imaging using transcranial focused ultrasound (tFUS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Test feasibility
Description
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.
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Volume assessment
Description
three-dimensional reconstructions of MRI slices will be manually segmented, resulting in a tumor volume that will be compared with MRI-segmented tumor volume.
Time Frame
Baseline
Title
Morphology assessment
Description
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.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Darrow, MD
Phone
612-624-6666
Email
darro015@umn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Clark Chen, MD
Phone
612-624-6666
Email
ccchen@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Darrow, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Darrow
Phone
612-624-6666
Email
darro015@umn.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Feasibility of Transcranial Focused Ultrasound to Measure Brain Tumor
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