Focused Ultrasound for Brain Cancer

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: InSightec

Must be taking: Antiseizure medications

Must not be taking: Anticoagulants, NSAIDs, Statins, VEGF inhibitors

Disqualifiers: Stroke, Diabetes, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for treating brain tumors using focused ultrasound. This technique uses sound waves, guided by MRI, to target and heat tumors. The main goal is to determine the safety of this method when applied through the skull. It targets individuals with brain tumors that are inoperable or unsuitable for radiation. Participants should have a tumor in the cerebral hemispheres that is clearly visible on an MRI and not too large. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for those with limited alternatives.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot be on anti-coagulant therapy or medications that increase the risk of bleeding. If you are on anti-seizure medication, you must continue taking it before the procedure.

What prior data suggests that this method is safe for brain cancer treatment?

Research shows that MRI-guided focused ultrasound, such as the ExAblate transcranial system, is under study for safety in treating brain tumors. Studies indicate that this method is generally well-tolerated. For instance, an early study treated three patients with brain tumors and found the method workable with manageable side effects. Additional safety data show that the treatment gradually increases ultrasound energy, reducing risks. While side effects can occur, they are usually mild and manageable. The FDA has already approved the ExAblate system for other uses, indicating a strong safety record. Overall, available data suggest that the treatment was safe in earlier studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for brain cancer, which often involve invasive surgery, chemotherapy, or radiation, the ExAblate transcranial system offers a non-invasive approach using MR Guided Focused Ultrasound. This technique uses high-intensity sound waves to target and destroy tumor cells without harming surrounding healthy tissue. Researchers are excited about this method because it minimizes damage to the brain and reduces recovery time, potentially leading to fewer side effects and improved quality of life for patients. Additionally, its precision could make it effective for treating tumors that are hard to reach with traditional surgery.

What evidence suggests that the ExAblate transcranial system is effective for brain cancer?

Research has shown that the ExAblate transcranial system, which uses focused ultrasound, could be promising for treating brain tumors. This technology, tested in this trial, targets brain tumors through the skull and might bypass the blood-brain barrier. The blood-brain barrier usually prevents many treatments from reaching the brain, so this method could be revolutionary. Although the trial currently focuses on safety, early results suggest that this approach could improve treatment outcomes in the future. Initial tests in models have also shown that it might enhance the effectiveness of other therapies by better targeting tumors. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for men and women aged 18-70 with brain tumors not advised for surgery or radiation. Participants must be able to consent, have a Karnofsky rating of 70-100, an ASA score of 1-2, and communicate during the procedure. Tumors should be in the cerebral hemispheres, clearly defined on MRI scans, less than 2.5 cm in diameter or 8 cm3 in volume.

Inclusion Criteria

ASA score 1-2.

The part of my tumor being treated is smaller than 2.5 cm across or 8 cm3.

My doctor has not recommended surgery or radiation for my metastatic cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MRI-guided focused ultrasound thermal ablation of brain tumors

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with contrast MRI and clinical exams

3 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• ExAblate transcranial system

Trial Overview The study tests the safety of using MRI-guided focused ultrasound (ExAblate transcranial system) to heat and destroy brain tumor tissue through an intact skull. It's a preliminary step to determine safety before assessing how well it works as a treatment.

How Is the Trial Designed?

Group I: ExAblate transcranial system Experimental Treatment 1 Intervention

MR Guided Focused Ultrasound

Who Is Running the Clinical Trial?

InSightec

Lead Sponsor

Trials

92

Recruited

3,800+

Dr. Maurice R. Ferré

InSightec

Chief Executive Officer

MD

Dr. Arjun Desai

InSightec

Chief Medical Officer

MD

Published Research Related to This Trial

The ExAblate 4000 system, designed for treating central nervous system disorders, successfully created thermal ablative lesions in all 22 swine subjects, demonstrating its efficacy in achieving targeted brain ablation with temperatures ranging from 52-65°C.

The procedure was well tolerated with minimal complications, such as incremental hemorrhage and necrosis, indicating a high safety margin for using MR-guided high-intensity focused ultrasound (MRgHIFU) in treating various cerebral pathologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sonoablation and application of MRI guided focused ultrasound in a preclinical model. Zibly, Z., Graves, CA., Harnof, S., et al.[2014]

Low-intensity MR-guided focused ultrasound combined with microbubbles shows promise for safely delivering drugs to the central nervous system by temporarily opening the blood-brain barrier, which is crucial for treating brain cancers.

Preclinical studies have demonstrated the safety and preliminary efficacy of this method in animal models, suggesting it could be a noninvasive and repeatable approach for targeting drug delivery in neuro-oncology patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-Intensity MR-Guided Focused Ultrasound Mediated Disruption of the Blood-Brain Barrier for Intracranial Metastatic Diseases. Meng, Y., Suppiah, S., Surendrakumar, S., et al.[2020]

Modern transcranial magnetic resonance-guided focused ultrasound is a non-invasive treatment that effectively targets and destroys specific areas of brain tissue, making it a promising option for various neurological disorders.

This technique uses real-time MR thermography to ensure safety by monitoring tissue temperatures, allowing for precise ablation without damaging surrounding brain structures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Frequency Ultrasound Ablation in Neurosurgery. Pomeraniec, J., Elias, WJ., Moosa, S.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT00147056

MRI-Guided Focused Ultrasound Feasibility Study for Brain ... The purpose of this study is to evaluate the safety of MRI-guided focused ultrasound thermal ablation of brain tumors performed through intact human skull using ...

2. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf15/P150038B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) Once the ExAblate Neuro is aligned, treatment with transcranial focused ultrasound energy is initiated in stepwise increments called sonications.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4687492/

Transcranial MR-Guided Focused Ultrasound - PubMed Central Ultrasound-mediated blood-brain/blood-tumor barrier disruption improves outcomes with trastuzumab in a breast cancer brain metastasis model. Journal of ...

4. dana-farber.org dana-farber.org/clinical-trials/13-016

A Study to Evaluate the Safety and Feasibility of ... The purpose of this study is to evaluate the safety of MRI-guided focused ultrasound thermal ablation of brain tumors performed through intact human skull ...

5. withpower.com withpower.com/trial/exablate-for-brain-cancer-be78e

ExAblate for Brain Cancer · Info for Participants The ExAblate Transcranial System is unique because it uses focused ultrasound to target brain tumors, potentially bypassing the blood-brain barrier that ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2939497/

Transcranial MRI-guided focused ultrasound surgery of brain ... This work evaluated the clinical feasibility of transcranial MRI-guided focused ultrasound surgery (TcMRgFUS). In initial trials in three glioblastoma ...

7. fusfoundation.org fusfoundation.org/diseases-and-conditions/brain-tumors/

Brain Tumors Learn about clinical trials that are investigating the use of focused ultrasound to treat Brain Tumors.