Sound waves may unlock Brain's barrier to fight tumors
NCT ID NCT05733312
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study uses focused ultrasound to temporarily open the blood-brain barrier during brain tumor surgery. Researchers will place tiny catheters to sample fluid from different brain areas to see how the barrier affects the tumor environment. Only 6 adults with large brain tumors will take part, and the goal is to gather information, not to treat the tumor.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- focused ultrasound (ExAblate Neuro device)
- What this could lead to
- If successful, this could reveal how the blood-brain barrier affects drug delivery to brain tumors, potentially guiding future treatments.
- What could go wrong
- This is a very small, early-stage study (6 people) focused on measurement, not treatment. It may not lead to direct benefits for participants.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 6 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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Mayo Clinic Minnesota
RECRUITINGRochester, Minnesota, 55905, United States
Contact Email: •••••@•••••
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