Actively Recruiting
Extracellular Impact of Ultrasound-induced Blood-brain Barrier Disruption
Led by Mayo Clinic · Updated on 2026-01-30
6
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study seeks to determine the impact of focused ultrasound (FUS) on the composition of the tumor extracellular microenvironment. Researchers will evaluate regions that are very abnormal, as well as regions that have less evidence of disease. A sub-portion of each of these areas will be targeted by focused ultrasound. Microdialysis catheters will then be placd into each region that has and has not been exposed to FUS (total of 4 catheters) to determine how FUS impacts the the brain and tumor extracellular metabolome, including concentration of routine drugs systemically administered prior to, and during surgery. Researchers hope that this information will help reveal the relative contribution of blood-derived compounds to the tumor microenvironment. If successful, microdialysis could be leveraged in the future to simultaneously evaluate pharmacokinetic and pharmacodynamic impacts of future candidate therapies, including those delivered with the aid of FUS.
CONDITIONS
Official Title
Extracellular Impact of Ultrasound-induced Blood-brain Barrier Disruption
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical and radiographic evidence of a diffuse glioma or prior diagnosis of diffuse glioma
- Tumor size of 3 cm or larger allowing half the tumor to be targeted by FUS
- Planned neurosurgical tumor resection as part of routine care
- Written informed consent for the study and biorepository participation
- ECOG performance status of 0, 1, or 2
- Willingness to undergo neurosurgical resection at Mayo Clinic (Rochester, MN)
You will not qualify if you...
- Not appropriate surgical candidates due to medical history or uncontrolled illness
- Pregnant or nursing women, prisoners, mentally handicapped individuals
- Contraindication to Definity��
- Cardiac or coagulation diseases such as recent myocardial infarction, pacemaker, unstable arrhythmia, congestive heart failure, or left ventricular ejection fraction below 50%
- Blood-borne infections that risk meningitis or brain abscess with BBB disruption
- Active uncontrolled seizure disorder or active drug/alcohol disorder
- Requirement for 5-ALA for optimal resection (not permitted in this study)
- Increased risk of FUS-related complications due to skull anatomy based on pre-op CT assessment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mayo Clinic Minnesota
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
N
Neurologic Surgery Research Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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