MRI Guided Focused Ultrasound for Fibroids

(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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment method called Symphony MRI-guided High Intensity Focused Ultrasound (HIFU) to reduce leiomyomas, commonly known as fibroids, which are non-cancerous growths in the uterus. The goal is to determine if this method can safely and effectively shrink fibroids and ease symptoms over time. Ideal participants are those who experience bothersome fibroid symptoms and are pre- or peri-menopausal, with a uterine size less than 24 weeks.

As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for fibroids.

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 prior data suggests that the Symphony MRI guided High Intensity Focused Ultrasound system is safe for treating leiomyomas?

Research has shown that High-Intensity Focused Ultrasound (HIFU) is generally safe. Most individuals experience only mild side effects, such as temporary redness and swelling, which typically resolve quickly. One study found that combining HIFU with other treatments improved skin tightness by 96.4%, demonstrating its safety and effectiveness.

However, some safety concerns exist, particularly near certain body areas, requiring careful planning of the treatment. Overall, HIFU is considered well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for leiomyomas, which often include surgical options like myomectomy or hysterectomy, the Symphony MRI-guided High Intensity Focused Ultrasound (HIFU) offers a non-invasive approach. This treatment uses focused ultrasound waves guided by MRI to precisely target and destroy fibroid tissue, reducing the need for surgery and potentially cutting down on recovery time. Researchers are excited about this technique because it minimizes risks associated with surgery and offers the possibility of preserving the uterus, which is a significant advantage for women planning future pregnancies.

What evidence suggests that the Symphony MRI guided High Intensity Focused Ultrasound is effective for treating leiomyomas?

Research has shown that MRI-guided high-intensity focused ultrasound (MR-HIFU), the treatment under study in this trial, effectively treats uterine fibroids, also known as leiomyomas. Studies have found that this noninvasive method can reduce fibroid size and improve patients' quality of life. For instance, a review of 10 studies found that MR-HIFU therapy significantly reduced fibroid size and eased symptoms. This technique uses focused ultrasound with real-time MRI to accurately target fibroid tissue. Overall, evidence supports MR-HIFU as a promising treatment for reducing fibroid size and symptoms. ^{2 6 7 8 9}

Who Is on the Research Team?

David Elizabeth

Principal Investigator

Sunnybrook Reserach Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3266576/

MR-guided high-intensity focused ultrasound for ... MR-HIFU is a unique noninvasive tumour ablation technique because of the combination of focused ultrasound with real-time MR guidance.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03323905?cond=fibroids&term=Sunnybrook&rank=4

Single Arm Study Using the Symphony -- MRI Guided ... This study will help determine the feasibility to ablate leiomyomas, as measured by MR thermometry and contrast enhanced imaging. In addition, the study will ...

3. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/full/10.1111/aogs.15086

Magnetic resonance guided high intensity focused ultrasound ... In this paper, we present the results of our prospective single-center study demonstrating the effectiveness of MR-HIFU in treating uterine ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2211568418300688

High intensity focused ultrasound: The fundamentals ... Multiple studies documented improved quality of life and reduced uterine leiomyoma sizes after HIFU therapy. Clark et al. conduced a meta-analysis of 10 studies ...

5. insightsimaging.springeropen.com insightsimaging.springeropen.com/articles/10.1186/s13244-021-01128-w

Lessons learned during implementation of MR-guided High ... Our findings describe the learning-curve during the implementation of MR-HIFU and include straightforward suggestions to shorten learning-curves for future ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10917599/

Safety and Efficacy of High-Intensity Focused Ultrasound ... Combining HIFU with MRF therapy improved GAIS scores by 96.4%, indicating a secure and efficient skin-tightening method.

7. mdpi.com mdpi.com/2076-3417/15/9/4958

Complications and Risks of High-Intensity Focused ... The findings confirm that HIFU is generally safe and effective, with most complications being mild and transient, such as temporary erythema, swelling, and ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4241267/

Safety limitations of MR‐HIFU treatment near interfaces This study provides useful information to better understand the limitations and safety concerns of performing MR‐HIFU treatments with commercial ...

9. anthem.com anthem.com/medpolicies/abc/active/mp_pw_a050053.html

MED.00057 MRI Guided High Intensity Focused ... This document addresses magnetic resonance imaging (MRI) guided high intensity focused ultrasound (HIFU) ablation, also known as magnetic resonance guided ...