Extracellular Impact of Ultrasound-induced Blood-brain Barrier Disruption

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT05733312
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • InSightec's ExAblate Neuro Model 4000 Type 2.0 (220 KHz) system — DEVICE
    Focused ultrasound which targets energy to a specific area in the brain based on imaging and disrupts the blood brain barrier which keeps certain drugs and other molecules out of the brain.

Study Details

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.

Key Dates

Start date
Jan 24, 2024
Status verified
Jan 2026
Primary completion
Jan 15, 2027
Completion
Jan 15, 2027

Study Design

Enrollment
6 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Focused Ultrasound
    Subjects with known or suspected glioma (≥3cm) undergoing routine planned neurosurgical resection will undergo a focused ultrasound prior to the surgery with the InSightec's ExAblate Neuro Model 4000 Type 2.0 (220 KHz) system

Primary Outcome Measure

Adverse events [ Time Frame: 3 months post-surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic MinnesotaRochesterMinnesota55905
Neurologic Surgery Research Team
[email protected]
507-266-6858
Clinical Trials Referral Office
[email protected]
855-776-0015
Terence C. Burns, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Rochester, MN

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Mayo Clinic Minnesota· Rochester, MN

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