Focused Ultrasound Therapy
Focused ultrasound is a rapidly evolving, noninvasive therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with brain tumors. This novel technology focuses beams of ultrasonic energy precisely and accurately on targets deep in the brain without damaging surrounding normal tissue.
How it Works
Where the beams converge, the ultrasound produces a variety of therapeutic effects enabling treatment without incisions or radiation. These include temporary opening of the blood-brain barrier, designed to improve levels in the brain of therapeutic agents; thermal ablation; activation of sono-sensitive agents at the target; and combining with radiation therapy for a more pronounce effect. There is also a study using focused ultrasound prior to surgery to help mark the extend of the tumor extension.
Current treatments for brain tumors include surgery, radiation therapy, and chemotherapy, all of which have limitations and side effects.
Focused ultrasound, used alone or in combination with conventional therapies, has the potential for several advantages.
- Focused ultrasound is non-invasive, so it does not carry added concerns like surgical wound healing or infection.
- Focused ultrasound can reach the desired target without damaging surrounding tissue.
- Focused ultrasound does not include the use of ionizing radiation
- Enhanced chemotherapy dose for the target, with less impact to the rest of the patient.
- It can be repeated, if necessary.
The following clinical trials are recruiting patients with brain tumors for focused ultrasound treatment:
Exablate Blood-Brain Barrier Disruption for Glioblastoma in Patients Undergoing Standard Chemotherapy
A clinical trial in Milan, Italy is investigating the use of focused ultrasound to open the blood-brain barrier (BBB) and allow chemotherapeutic agents to more efficiently reach the tumors of patients with glioblastoma.
Exablate Blood-Brain Barrier Disruption for Glioblastoma in Patients Undergoing Standard Chemotherapy
A clinical trial at Severance Hospital, a part of Yonsei University Health System, in Seoul, Korea, is investigating the use of focused ultrasound to open the blood-brain barrier (BBB) and allow chemotherapeutic agents to more efficiently reach the tumors of patients with glioblastoma.
Exablate Blood-Brain Barrier Disruption With Carboplatin for the Treatment of rGBM
New clinical trials have opened in the United States, Canada, and Korea that use focused ultrasound to temporarily open the blood brain barrier (BBB) prior to carboplatin therapy for patients with recurrent glioblastoma.
Exablate Blood Brain Barrier Disruption (BBBD) for Planned Surgery in Glioblastoma
This clinical trial is a planned continuation of a prior study that will open blood-brain barrier prior to surgery in patients with glioblastoma.
An Ultrasound-Based Blood Brain Barrier Opening Clinical Trial Using Albumin Bound Paclitaxel to Treat Recurrent Glioblastoma
This invasive procedure that is similar to focused ultrasound uses an implanted device to treat patients with recurrent glioblastoma.
Blood-Brain Barrier Disruption (BBBD) for Liquid Biopsy in Subjects With Glioblastoma Brain Tumors
A clinical trial for patients with Glioblastoma for liquid biopsy has also begun recruiting patients.
The following studies concern focused ultrasound combined with radiation therapy.
A study combining focused ultrasound and radiation therapy in patients with glioblastoma
This study has been completed.
The following studies concern focused ultrasound and sonodynamic therapy.
A study of sonodynamic therapy for patient with high grade glioma
A new clinical trial in the US is using sound activated drugs to treat patients with recurrent high grade glioma, including glioblastoma.
A study of sonodynamic therapy in patients with newly diagnosed glioblastoma
This study will use low frequency focused ultrasound to activate drugs in patients with newly diagnosed glioblastoma.
The following studies concern tumors in pediatric patients.
Phase 1/2 Study of Sonodynamic therapy to treat Type 2 Patients with DIPG
A clinical trial is using sonodynamic therapy to treat pediatric patients who are five years and older with DIPG (diffuse intrinsic pontine glioma).
A Feasibility Safety Study of Benign Centrally-Located Intracranial Tumors in Pediatric and Young Adult Subjects
Centrally located intracranial benign tumors that require intervention in pediatric and young adult patients. Click here for a list of tumors treated in this study.
A clinical trial by Carthera is organizing and will be treating recurrent malignant brain tumors in children in France.
The following studies concern treatment of tumors from the body that have metastasized to the brain.
A clinical trial for patients with breast cancer that has metastasized to their brain is enrolling patients in Canada. The team will us focused ultrasound to open the blood-brain barrier to allow therapeutic medications to more effectively reach the tumor in their brain. This study is only open to Canadian citizens. A summary of the first four patients has been published.
A clinical trial for patients with lung cancer that has metastasized to the brain has begun recruiting patients in the US.
The following study concerns a wide variety of brain tumors.
This clinical trial is for a wide variety of brain tumors that are planned to be biopsied. This study is only open to Canadian citizens.
For a full list of known brain tumor clinical trials, please see here.
Regulatory Approval and Reimbursement
Focused ultrasound is not approved by any regulatory bodies worldwide as a treatment for brain tumors, nor is the treatment reimbursed by medical insurance providers.
Preclinical Laboratory Studies
Preclinical studies are underway to investigate the use of various mechanisms of focused ultrasound in the treatment of brain tumors. Examples of these studies include:
- Focused ultrasound to temporarily disrupt the BBB and deliver a variety of chemotherapy or immunotherapy drugs, including the dosing and timing (e.g. frequency) of drug administration.
- Focused ultrasound to induce an immune response, including a multi-site study investigating the type of immune response elicited by different “modes” of energy delivery.
- Focused ultrasound to enable targeted delivery and/or activation of drugs via carrier vehicles (e.g. microbubbles, nanoparticles, liposomes) to enable delivery of high concentrations in the tumor with minimal systemic side effects.
- Non-thermal mechanical destruction of tumor using a type of focused ultrasound called histotripsy.
There are many government bodies and patient groups dedicated to brain tumors, including the following:
- Medline Plus: A service of the U.S. National Library of Medicine and NIH
- National Cancer Institute’s Brain Tumor Page
- American Brain Tumor Association
- National Brain Tumor Society
Suggested Reading: Focused Ultrasound for Glioblastoma (PDF), June 2021.
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