What side effects are associated with this type of intervention?

Common treatments for brain tumors, including Focused Ultrasound (FUS), chemotherapy, radiation therapy, and stereotactic radiosurgery, have various side effects. FUS, which alters the tumor extracellular microenvironment and drug distribution, may cause localized tissue damage and inflammation. Chemotherapy can lead to nausea, vomiting, myelosuppression, and peripheral neuropathy. Radiation therapy often results in fatigue, skin changes, and potential neurocognitive decline. Stereotactic radiosurgery may cause acute symptoms like headaches and nausea, and late complications such as necrosis within the treatment volume. Each treatment's side effects depend on the specific therapy and patient factors.

What prior FDA approvals exist?

The FDA has approved several treatments for brain tumors, including traditional chemotherapy, targeted therapies, and immunotherapies. Notably, treatments like bevacizumab (Avastin) have been approved for recurrent glioblastoma, which works by inhibiting angiogenesis. While there are no direct FDA approvals for treatments using Focused Ultrasound (FUS) to alter the tumor microenvironment, this method is being actively researched to enhance drug delivery and efficacy. The innovative approach of FUS could potentially complement existing therapies by improving drug penetration and distribution within the tumor.

What other types of research exist?

Promising novel alternatives to Focused Ultrasound (FUS) for brain tumor patients include: 1) Masitinib, a selective oral tyrosine kinase inhibitor that targets neuroinflammatory processes and shows potential in slowing disease progression in ALS, which may be applicable to brain tumors. 2) Neurotrophic factor (NTF)-secreting mesenchymal stromal cells (MSC-NTF cells) and other stem cell treatments, which have shown safety and some efficacy in early studies. 3) Bevacizumab, an anti-angiogenic therapy, which has been used in combination with other treatments for recurrent brain tumors. These alternatives are currently under investigation and may offer new avenues for treatment in 2024.

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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

No Placebo-Only Group

Summary

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.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months post-surgery

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse events

Number of microdialysate aliquots

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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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.