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Trial Title:
Feasibility of Transcranial Focused Ultrasound to Measure Brain Tumor
NCT ID:
NCT05755399
Condition:
Cranial Neurosurgery
Conditions: Official terms:
Brain Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Brain imaging using transcranial focused ultrasound (tFUS)
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.
Arm group label:
Experimental group
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.
Criteria for 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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Minnesota
Address:
City:
Minneapolis
Zip:
55414
Country:
United States
Status:
Recruiting
Contact:
Last name:
David Darrow
Phone:
612-624-6666
Email:
darro015@umn.edu
Start date:
October 19, 2023
Completion date:
November 30, 2027
Lead sponsor:
Agency:
University of Minnesota
Agency class:
Other
Source:
University of Minnesota
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05755399
