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Focused Ultrasound for Brain Tumors

This study is looking at how focused ultrasound, using the InSightec's ExAblate Neuro Model 4000 Type 2.0 system, affects brain tumors. This system uses energy to temporarily open the blood-brain barrier, which normally prevents many drugs from reaching the brain. Researchers want to see how this affects the chemicals and drugs found in the tumor and surrounding brain tissue. You might be able to join if you have a diffuse glioma (a type of brain tumor) that is at least 3 centimeters in size and can be removed by surgery. The study will measure any side effects at 3 months after surgery and count the number of fluid samples taken from the brain. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 6 participants. It is designed to evaluate the effects of focused ultrasound immediately before brain tumor removal surgery.
What's involved
You would undergo focused ultrasound treatment right before your planned brain tumor removal surgery. During surgery, small catheters will be placed to collect fluid samples from your brain.
Compensation
Not stated in the trial record.
Follow-up
Adverse events and the number of fluid samples will be measured at 3 months after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05733312

Extracellular Impact of Ultrasound-induced Blood-brain Barrier Disruption

Recruiting
NAAges 18+InterventionalBasic science
Mayo Clinic
~6 participants
Updated 2026-01-30 on ClinicalTrials.gov
What's tested:InSightec's ExAblate Neuro Model 4000 Type 2.0 (220 KHz) system

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse events
Measured over 3 months post-surgery
+1 more outcome measured

Conditions

Brain Tumor

Explore related trials

Diffuse Glioma

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Terence C. Burns, M.D., Ph.D. · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Neurologic Surgery Research Team
[email protected]
507-266-6858
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Clinical and radiographic evidence suggesting a diagnosis of a diffuse glioma, or a prior diagnosis of a diffuse glioma, which is large enough (≥3cm) for half of the tumor to be targeted by FUS, but small enough for the standard-of-care resection to incorporate some regions of relatively normal brain adjacent to tumor.
Planned neurosurgical resection of this suspected or previously diagnosed brain tumor as part of routine clinical care.
Provide written informed consent for the current study and the Neuro-Oncology biorepository for archiving of microdialysate and blood samples collected on this protocol.
ECOG performance status (PS) 0, 1, or 2. Willing to undergo neurosurgical resection at Mayo Clinic (Rochester, MN).

Exclusion

Patients who are not appropriate surgical candidates due to current or past medical history or uncontrolled concurrent illness which limits safety of or compliance to study proceedings.
Vulnerable populations: pregnant or nursing women, prisoners, mentally handicapped.
Contraindication to Definity®.
Cardiac disease or coagulative disease (such as cerebral or systemic vasculopathy, abnormal platelets, documented MI within 6 months of enrollment, pacemaker, hemodynamically unstable cardiac arrhythmia, unstable congestive heart failure, or left ventricular ejection fraction \<50%), that would preclude the use of Definity ®, FUS-induced BBB disruption, or surgical resection.
Any blood-borne infection that may lead to meningitis or brain abscess due to BBB-disruption.
Active seizure disorder that is not attributable to the patient's tumor which is not controlled by medication or due to active drug or alcohol disorder which may be worsened by BBB-disruption.
Patients for whom the surgeon feels 5-ALA would be required to perform an optimal resection, since 5-ALA will not be permitted for patients participating in this study.
Patients who are at risk of FUS-related complications due to potential risks associated with skull anatomy as determined by pre-operative CT assessment, based on skull thickness, curvature, density, or other features that would increase the risk of skull complications with FUS.

What this trial measures

  • Adverse events3 months post-surgery

    Number of adverse deemed related to FUS and/or intraoperative microdialysis after the integration of FUS and intraoperative microdialysis into the neurosurgical workflow for tumor resection

  • Number of microdialysate aliquots3 months post-surgery

    Number of microdialysate aliquots collected containing \>10 μL of volume