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Procedure

Focused Ultrasound for Brain Tumor

N/A
Recruiting
Led By Terence C. Burns, M.D., Ph.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post-surgery
Awards & highlights

Summary

This trial looks at how focused ultrasound (FUS) affects tumor microenvironments. Researchers will compare areas with and without FUS to measure changes in the brain & tumor molecules. It could lead to new ways to study cancer drugs & therapies.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include risks associated with general surgical procedures such as infection and bleeding. Specific side effects related to the use of focused ultrasound and disruption of the blood-brain barrier are not detailed but could involve neurological changes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months post-surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse events
Number of microdialysate aliquots

Trial Design

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for brain tumors include chemotherapy, which uses drugs to kill cancer cells or stop them from growing; radiotherapy, which uses high-energy radiation to destroy cancer cells; and surgery, which physically removes the tumor. Focused Ultrasound (FUS) is a novel treatment being studied for its ability to disrupt the blood-brain barrier, allowing for better drug delivery directly to the tumor site. This is significant for brain tumor patients as it can potentially enhance the effectiveness of chemotherapy and other treatments by improving drug penetration and altering the tumor microenvironment, leading to better treatment outcomes.
A guide through conventional and modern cancer treatment modalities: A specific focus on glioblastoma cancer therapy (Review).Focused ultrasound for the treatment of glioblastoma.Imaging-guided focused ultrasound-induced thermal and sonodynamic effects of nanosonosensitizers for synergistic enhancement of glioblastoma therapy.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,255 Previous Clinical Trials
3,835,400 Total Patients Enrolled
Terence C. Burns, M.D., Ph.D.Principal InvestigatorMayo Clinic
3 Previous Clinical Trials
339 Total Patients Enrolled
Terence Burns, MDPrincipal InvestigatorMayo Clinic

Media Library

InSightec's ExAblate Neuro Model 4000 Type 2.0 (220 KHz) system (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05733312 — N/A
Brain Tumor Research Study Groups: Focused Ultrasound
Brain Tumor Clinical Trial 2023: InSightec's ExAblate Neuro Model 4000 Type 2.0 (220 KHz) system Highlights & Side Effects. Trial Name: NCT05733312 — N/A
InSightec's ExAblate Neuro Model 4000 Type 2.0 (220 KHz) system (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05733312 — N/A
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