Single Arm Study Using the Symphony -- MRI Guided Focused Ultrasound System for the Treatment of Leiomyomas

(HIFUSB Trial)

Overseen By Jessica Marer

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Must not be taking: Anticoagulants

Disqualifiers: Pregnancy, Endometriosis, Ovarian tumor, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

50 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on anti-coagulation therapy, you may not be eligible to participate.

What data supports the effectiveness of the treatment Symphony MRI guided High Intensity Focused Ultrasound (HIFU)?

Research shows that MRI-guided High Intensity Focused Ultrasound (HIFU) is a promising non-invasive treatment for various tumors, including those in the prostate, breast, and brain. It has been tested for safety and feasibility in several studies, suggesting it could be an alternative or addition to traditional cancer treatments like surgery and chemotherapy. ^{1 2 3 4 5}

Is Symphony MRI guided High Intensity Focused Ultrasound (HIFU) generally safe for humans?

Research on high-intensity focused ultrasound (HIFU) for conditions like uterine fibroids, prostate cancer, and pancreatic cancer shows that it has been studied for safety. While specific adverse events (unwanted side effects) can occur, these studies suggest that HIFU is generally considered safe for human use in these conditions. ^{6 7 8 9 10}

How does Symphony MRI guided High Intensity Focused Ultrasound (HIFU) treatment differ from other treatments for this condition?

Symphony MRI guided High Intensity Focused Ultrasound (HIFU) is unique because it is a non-invasive treatment that uses focused ultrasound waves to heat and destroy targeted tissue, guided by real-time MRI imaging. This allows for precise targeting of tumors or other conditions without the need for surgery, making it a promising alternative to traditional treatments like surgery or radiation. ^{1 4 11 12 13}

What is the purpose of this trial?

This trial is testing a new device that uses MRI and focused ultrasound waves to treat uterine fibroids. It aims to see if this method can effectively reduce fibroid size and symptoms in patients. The study will also check if the treatment is safe. This technique has a history of being used to reduce fibroid size and symptoms.

Research Team

David Elizabeth

Principal Investigator

Sunnybrook Reserach Institute

Eligibility Criteria

This trial is for pre- or peri-menopausal women under 310 lbs with uterine fibroids, who can use contraception and attend all visits. They should have a waist less than 43 inches, fibroids accessible by the MRI-HFU device, and no extensive scarring or tattoos that could interfere with treatment.

Inclusion Criteria

You weigh less than 140 kg or 310 lbs.

You must agree to use a reliable form of birth control.

Total planned ablation volume of all fibroids should not exceed 500 ml.

Exclusion Criteria

Bowel loops in the ultrasound beam path

Patient with unstable medical conditions

Patients with coagulopathy or under current anti-coagulation therapy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo MRI-guided high intensity focused ultrasound ablation of leiomyomas

1 year

Multiple visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including reduction in fibroid size and symptom severity

1 year

Treatment Details

Interventions

• Symphony MRI guided High Intensity Focused Ultrasound (HIFU)

Trial Overview The study tests the Symphony MRI-guided High Intensity Focused Ultrasound (HIFU) system on leiomyomas (fibroids). It aims to see if this method can safely shrink fibroids and reduce symptoms without surgery over a period of 12 months.

Participant Groups

Group I: MR Guided High Intensity Focused Ultrasound Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Arrayus Technologies Inc.

Industry Sponsor

Trials

1

Recruited

50+

Sunnybrook Research Institute

Collaborator

Trials

33

Recruited

216,000+

Arrayus Technologies Inc.

Collaborator

Trials

1

Recruited

50+

Findings from Research

High intensity focused ultrasound (HIFU) is a non-invasive treatment option for various tumors, showing promising safety and feasibility in clinical studies over the past decade.

HIFU may serve as a viable alternative or complement to traditional cancer treatments like surgery and chemotherapy, and future developments could enable it to facilitate targeted drug and gene delivery for localized cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and future applications of high intensity focused ultrasound in cancer. Al-Bataineh, O., Jenne, J., Huber, P.[2022]

In a study of 372 women with symptomatic uterine fibroids who underwent MR-HIFU, the overall rate of adverse events (AEs) was low at 8.9%, with no major AEs reported, indicating that MR-HIFU is a safe treatment option.

The only significant risk factor for AEs was the treatment of type II uterine fibroids, suggesting that while MR-HIFU is generally safe, certain types of fibroids may carry a higher risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occurrence of adverse events after magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) therapy in symptomatic uterine fibroids-a retrospective case-control study. Kociuba, J., Łoziński, T., Zgliczyńska, M., et al.[2023]

In a Phase II/III clinical trial involving 402 patients with localized prostate cancer, high-intensity focused ultrasound (HIFU) demonstrated a high negative biopsy rate of 87.2%, indicating its efficacy as a treatment option.

The study suggests that HIFU is a viable primary treatment for localized prostate cancer, especially in low-risk patients, who showed a 92.1% negative biopsy rate, with a mean follow-up duration of over a year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity focused ultrasound and localized prostate cancer: efficacy results from the European multicentric study. Thüroff, S., Chaussy, C., Vallancien, G., et al.[2016]

High-intensity focused ultrasound (HIFU) is a safe and non-invasive treatment option for advanced pancreatic cancer, as shown in a study of 224 cases with no severe complications reported.

While some patients experienced mild side effects like increased serum amylase levels and gastrointestinal dysfunction, the overall safety profile was positive, indicating that careful preparation and execution are essential for successful outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety evaluation of high-intensity focused ultrasound in patients with pancreatic cancer. Wang, K., Zhu, H., Meng, Z., et al.[2022]

High-intensity focused ultrasound (HIFU) is a promising non-invasive treatment option for various solid tumors, including those in the pancreas, liver, and prostate, showing potential as an alternative to traditional oncologic therapies.

HIFU can be combined with imaging techniques like MRI and ultrasound for real-time monitoring during treatment, enhancing its safety and efficacy while minimizing complications associated with open surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Introduction to High Intensity Focused Ultrasound: Systematic Review on Principles, Devices, and Clinical Applications. Izadifar, Z., Izadifar, Z., Chapman, D., et al.[2020]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical and future applications of high intensity focused ultrasound in cancer. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Image-directed, tissue-preserving focal therapy of prostate cancer: a feasibility study of a novel deformable magnetic resonance-ultrasound (MR-US) registration system. [2021]

3. England pubmed.ncbi.nlm.nih.gov

MR-guided transcranial brain HIFU in small animal models. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Real-time 3D ultrasound based motion tracking for the treatment of mobile organs with MR-guided high-intensity focused ultrasound. [2019]

5. England pubmed.ncbi.nlm.nih.gov

An MRI-conditional motion phantom for the evaluation of high-intensity focused ultrasound protocols. [2017]

6. England pubmed.ncbi.nlm.nih.gov

Occurrence of adverse events after magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) therapy in symptomatic uterine fibroids-a retrospective case-control study. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Complete high-intensity focused ultrasound in prostate cancer: outcome from the @-Registry. [2022]

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

High-intensity focused ultrasound and localized prostate cancer: efficacy results from the European multicentric study. [2016]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Safety evaluation of high-intensity focused ultrasound in patients with pancreatic cancer. [2022]

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

High-intensity focused ultrasound (HIFU) followed after one to two weeks by radical retropubic prostatectomy: results of a prospective study. [2019]

11. Switzerland pubmed.ncbi.nlm.nih.gov

An Introduction to High Intensity Focused Ultrasound: Systematic Review on Principles, Devices, and Clinical Applications. [2020]

12. Germany pubmed.ncbi.nlm.nih.gov

MR-guided HIFU treatment of symptomatic uterine fibroids using novel feedback-regulated volumetric ablation: effectiveness and clinical practice. [2013]

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

Hybrid ultrasound-MR guided HIFU treatment method with 3D motion compensation. [2019]