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

Trial Summary

What is the purpose of this trial?

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 the ExAblate transcranial system. We will collect data to establish the basic safety of this type of treatment as the basis for later studies that will evaluate its clinical efficacy.

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 data supports the effectiveness of the treatment ExAblate transcranial system for brain cancer?

Focused ultrasound, like the ExAblate transcranial system, is promising for brain cancer because it can precisely target brain tumors and help deliver drugs by temporarily opening the blood-brain barrier (a protective shield around the brain). While there is strong evidence from animal studies, human studies are still mainly focused on ensuring safety. ^{1 2 3 4 5}

How is the ExAblate transcranial system treatment different from other brain cancer treatments?

The ExAblate transcranial system uses focused ultrasound, a non-invasive technique, to target and destroy brain tumors by heating them, while also potentially opening the blood-brain barrier to enhance drug delivery. This approach is unique because it allows precise targeting without surgery and can be guided in real-time using MRI to ensure accuracy and safety. ^{3 4 6 7 8}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Current state of therapeutic focused ultrasound applications in neuro-oncology. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Emerging Therapeutic Strategies for Brain Tumors. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

From Focused Ultrasound Tumor Ablation to Brain Blood Barrier Opening for High Grade Glioma: A Systematic Review. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Focused ultrasound for brain metastases: an update on global clinical trials. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Low-Intensity MR-Guided Focused Ultrasound Mediated Disruption of the Blood-Brain Barrier for Intracranial Metastatic Diseases. [2020]

6. Scotland pubmed.ncbi.nlm.nih.gov

Sonoablation and application of MRI guided focused ultrasound in a preclinical model. [2014]

7. United States pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging-guided focused ultrasound for thermal ablation in the brain: a feasibility study in a swine model. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

High-Frequency Ultrasound Ablation in Neurosurgery. [2023]