ExAblate for Brain Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: InSightec

Must not be taking: Anticoagulants, NSAIDs, Statins, Immunosuppressants

Disqualifiers: Brain edema, Hemodynamic instability, Diabetes, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for treating brain tumors using focused ultrasound technology guided by MRI. The main goal is to determine if this method is safe and effective for patients with recurring or worsening brain tumors, such as glioma or metastatic brain cancer, who cannot undergo further surgery or radiation. Patients who have tried standard treatments but still have tumors in specific brain areas might be suitable candidates. The ExAblate Transcranial System uses sound waves to target the tumor without surgery. Participants must have clear tumor images on an MRI and tolerate certain medications before and after the procedure. As an unphased trial, this study offers patients the chance to explore innovative treatment options that could potentially improve their condition.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those on anti-coagulant therapy or medications that increase the risk of bleeding. You can continue taking corticosteroids to prevent or treat brain swelling.

What prior data suggests that the ExAblate Transcranial System is safe for treating brain tumors?

Research is testing the ExAblate Transcranial System for safety and effectiveness in treating brain tumors. Earlier studies used this system on brain tumors without opening the skull, focusing on safety and showing promising results.

In some initial trials, researchers tested the system on patients with glioblastoma, a type of brain cancer. These studies helped refine the device's safe use, and no major safety issues were reported, suggesting the treatment might be well-tolerated by patients.

The ExAblate System is not new; it has been used and studied in other research, which increases confidence in its safety. However, like any treatment, some risks may exist. Participants should discuss these risks with their doctor before joining any trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for brain cancer, which often involve surgery, radiation, and chemotherapy, the ExAblate Transcranial System offers a non-invasive option. This treatment uses focused ultrasound waves to target and destroy cancerous tissue in the brain without needing to make any incisions. Researchers are excited because this method potentially reduces the risks and recovery time associated with traditional surgical procedures. Additionally, the precision of the ultrasound waves may minimize damage to surrounding healthy brain tissue, which could lead to fewer side effects.

What evidence suggests that the ExAblate Transcranial System is effective for brain tumors?

Research has shown that the ExAblate Transcranial System could be a promising treatment for brain tumors. This system uses focused ultrasound waves to heat and destroy tumor cells without requiring surgery to open the skull. Studies have tested its safety, and early results indicate it can effectively target and damage tumor cells. While more information is needed to fully understand its efficacy, researchers are actively studying its potential benefits. Participants in this trial will receive the ExAblate Transcranial System as part of the study. Ongoing trials are also testing this system alongside other brain cancer treatments. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with brain tumors smaller than 2.5 cm in diameter or metastatic brain cancer that's worsened after radiotherapy. It's an option when surgery isn't suitable and the tumor is well-defined on MRI scans, located more than 2.5 cm from the skull's inner table, and patients can handle steroids before/after treatment.

Inclusion Criteria

Able and willing to give informed consent.

Tumor(s) are clearly defined on pre-therapy contrast enhanced MRI scans.

My glioma has returned or worsened despite standard treatments, and surgery or more radiation isn't recommended.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo MRI-guided focused ultrasound surgery using the ExAblate Transcranial Device

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the ExAblate treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ExAblate Transcranial System

Trial Overview The study tests the safety and feasibility of using ExAblate Transcranial System, a non-invasive MRI-guided focused ultrasound surgery method to treat brain tumors without traditional surgical procedures.

How Is the Trial Designed?

Group I: ExAblate Transcranial Device Experimental Treatment 1 Intervention

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 study demonstrates the successful use of a novel implantable convection-enhanced delivery (CED) system for carboplatin in a patient with recurrent glioblastoma, showing precise catheter placement and well-tolerated drug infusions.

Follow-up MRI results indicated a significant reduction in tumor volume from 42.6 ml to 24.6 ml after treatment, suggesting that CED of carboplatin may improve clinical outcomes for glioblastoma patients by effectively bypassing the blood-brain barrier.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel implantable catheter system with transcutaneous port for intermittent convection-enhanced delivery of carboplatin for recurrent glioblastoma. Barua, NU., Hopkins, K., Woolley, M., et al.[2022]

A review of 166 phase III randomized clinical trials published between 2011 and 2013 revealed frequent misreporting of adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE v3.0), indicating a significant issue in adherence to established guidelines.

Inappropriate grading of toxicities was common, with serious conditions like febrile neutropenia often graded too low, and less severe conditions like alopecia graded too high, which could mislead clinicians and affect treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use and misuse of common terminology criteria for adverse events in cancer clinical trials. Zhang, S., Liang, F., Tannock, I.[2018]

Brain and spinal tumors, affecting 1 in 1000 people by age 25, have a high mortality rate of 30-40%, but most patients survive with significant long-term disabilities due to brain injuries acquired before and after treatment.

Current drug delivery techniques are being explored to improve the effectiveness of treatments for brain tumors by enhancing drug penetration across the blood-brain barrier or bypassing it altogether, which could lead to better patient outcomes and the potential re-evaluation of previously ineffective drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Childhood Brain Tumors: A Review of Strategies to Translate CNS Drug Delivery to Clinical Trials. Rahman, R., Janowski, M., Killick-Cole, CL., et al.[2023]

In a study of 17 patients aged 2 to 25 years with unfavorable brain tumors, a combined treatment of chemotherapy and radiotherapy led to a median overall survival of 36 months, with 9 patients still alive at a median follow-up of 25 months.

While the treatment showed promise with 4 complete remissions and 2 partial remissions, it also resulted in severe toxicity, including one therapy-related death, highlighting the need for careful management of side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synchronous radiochemotherapy in unfavorable brain tumors of children and young adults. Urban, C., Benesch, M., Pakisch, B., et al.[2019]

In a study of 260 patients treated for brain and skull base tumors with photon and particle therapies, no unexpected severe toxicities were reported, indicating a favorable safety profile for these treatments.

The use of particle therapy, particularly protons and carbon ions, shows promise in potentially reducing the risk of secondary malignancies and improving neurocognitive outcomes, although longer follow-up is needed to confirm these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton and carbon ion radiotherapy for primary brain tumors and tumors of the skull base. Combs, SE., Kessel, K., Habermehl, D., et al.[2016]

A review of 77 studies involving 6384 patients found that stereotactic radiosurgery (SRS) combined with systemic therapies (like chemotherapy and immunotherapy) is safe, showing no significant increase in skin toxicities, bleeding, or radiation necrosis.

The median SRS dose was 20 Gy, and the findings support the continuation of systemic treatments alongside SRS for patients with brain metastases, indicating that this combination does not adversely affect patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of radiosurgery concurrent with systemic therapy (chemotherapy, targeted therapy, and/or immunotherapy) in brain metastases: a systematic review. Borius, PY., Régis, J., Carpentier, A., et al.[2021]

Citations

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

ExAblate for Brain Cancer · Info for Participants Brain and spinal tumors, affecting 1 in 1000 people by age 25, have a high mortality rate of 30-40%, but most patients survive with significant long-term ...

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

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) This data was collected as part of the safety assessment of the. ExAblate System. This outcome indicates that the ExAblate treatment does not ...

3. 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10301958/

Advances in Focused Ultrasound for the Treatment of Brain ... Current trials are underway to examine the efficacy of pembrolizumab (Keytruda) with the use of Exablate for metastatic brain cancer.

5. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf15/P150038S037B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The Exablate Model 4000 Type 1.0 & 1.1 System (“Exablate Neuro”) is a transcranial. MR image-guided focused ultrasound system that combines a ...

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. 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 ...