Trial Summary
What is the purpose of this trial?This trial uses Focused Ultrasound to target brain tumors in patients with large gliomas. The treatment aims to open up the tumor area, making it easier to deliver and assess drugs. Researchers hope this will improve understanding and treatment of these tumors. Focused Ultrasound (FUS) is a non-invasive technique that uses converging ultrasound waves to temporarily open the blood-brain barrier, enhancing drug delivery to brain tumors.
Eligibility Criteria
This trial is for adults with a suspected or diagnosed diffuse glioma brain tumor, large enough (≥3cm) to be partially targeted by focused ultrasound but small enough for standard surgery. Participants must be able to undergo surgery in Rochester, MN and have an ECOG performance status of 0-2. Pregnant women, prisoners, those mentally handicapped, or anyone with certain cardiac diseases or blood-borne infections are excluded.Inclusion Criteria
I am scheduled for brain surgery to remove a tumor.
Provide written informed consent for the current study and the Neuro-Oncology biorepository for archiving of microdialysate and blood samples collected on this protocol
I have a brain tumor that is the right size for focused ultrasound but can still be partially removed surgically.
+2 more
Exclusion Criteria
I have seizures not caused by my tumor, or a drug/alcohol problem, not controlled by medication.
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
+5 more
Participant Groups
The study tests the effect of focused ultrasound on brain tumors using InSightec's ExAblate Neuro Model system. It aims to understand how this technique alters the tumor microenvironment by comparing regions treated with FUS against untreated ones through microdialysis catheters.
1Treatment groups
Experimental Treatment
Group I: Focused UltrasoundExperimental Treatment1 Intervention
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
InSightec's ExAblate Neuro Model 4000 Type 2.0 (220 KHz) system is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as ExAblate Neuro Model 4000 Type 2.0 (220 KHz) system for:
- Essential tremor
- Parkinson's disease
- Neuropathic pain
🇪🇺 Approved in European Union as ExAblate Neuro Model 4000 Type 2.0 (220 KHz) system for:
- Essential tremor
- Parkinson's disease
- Neuropathic pain
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo Clinic MinnesotaRochester, MN
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Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor