Ultrasound Imaging for Fibroids

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Dr. Linda McLean

Disqualifiers: Uterine cancer, Pregnancy, Post-partum, others

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

Compensation: Varies

Number of Visits: 5

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is ultrasound imaging for fibroids generally safe for humans?

Ultrasound imaging, including the use of contrast agents, is generally safe for humans. Serious adverse reactions are rare, and most side effects, like headaches or nausea, are minor and go away on their own. ^{1 2 3 4 5}

How does ultrasound imaging for fibroids differ from other treatments?

Ultrasound imaging for fibroids, specifically using high-intensity focused ultrasound (HIFU), is unique because it is a non-invasive treatment that uses sound waves to target and shrink fibroids without surgery. This method offers a safer and quicker recovery compared to traditional surgical options like hysterectomy (removal of the uterus) or myomectomy (removal of fibroids). ^{6 7 8 9 10}

What is the purpose of this trial?

Uterine fibroids (leiomyomas, myomas, fibroids) are benign tumors of the uterus that can cause heavy menstrual bleeding, pain, and/or infertility. Fibroids can be managed with medication, surgery, or interventional radiology. While conservative methods that avoid surgical risks and complications are becoming more common, there are limitations to medical therapies including side effects, short durations of use, and incomplete response to treatment. To optimize patient outcomes, it is imperative clinicians and researchers better understand which patients may benefit from medical therapies and which may not. Fibroids with less blood supply can degenerate and take on a variety of histological characteristics (e.g. cystic, red, fatty, calcific) which may decrease response to medical management. These histological characteristics in degenerated fibroids correspond to altered mechanical properties, ranging from very soft to very hard. There is currently no guidance on how to predict medical responsiveness based on such fibroid characteristics. As a result, physicians treat patients empirically with medications, without the ability to counsel on effectiveness or failure rates. Our research goal is to understand if and how uterine fibroid tissue stiffness can predict response to medical therapies. To achieve this, the investigators will use a new ultrasound technology, called shear wave elastography (SWE), that non-invasively measures tissue stiffness and is currently used in practice for staging of chronic liver diseases; however, given that this technology is very new, evidence of its clinical application in gynecology is limited. Through implementing an innovative and multidisciplinary approach, the investigators will (1) systematically establish SWE as a feasible and reliable tool for measuring non-neoplastic myometrial and uterine fibroid tissue stiffness, and (2) use SWE to classify and monitor fibroid tissue properties in pre-menopausal women undergoing medical intervention for symptomatic uterine fibroids. Understanding the connection between pathological tissue properties and the success of medical therapies is essential to streamline assessment and intervention planning and improve overall patient outcomes for the many Canadian women who suffer from uterine fibroids.

Research Team

Sukhbir S Singh, MD, FRCSC

Principal Investigator

The Ottawa Hospital Research Institute

Linda McLean, PhD

Principal Investigator

University of Ottawa

Eligibility Criteria

This trial is for premenopausal women with regular menstrual cycles, aged 18 or older, who are scheduled to undergo treatment for symptomatic uterine fibroids. They must have fewer than six fibroids identified by imaging and no history of conditions that could affect tissue properties.

Inclusion Criteria

I have not gone through menopause.

I don't have any health conditions that affect tissue properties.

<6 fibroids identified by medical imaging

Exclusion Criteria

Pregnancy

<6 months post-partum

History of caesarean delivery

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment

Participants undergo shear wave elastography (SWE) and 3D ultrasound assessments of their uterus

1-2 weeks

1-2 visits (in-person)

Medical Intervention

Participants receive two 3-month courses of ulipristal acetate (UPA) and undergo SWE imaging before and after treatment

6 months

3 visits (in-person)

Surgical Intervention

Participants undergo elective hysterectomy or myomectomy with tissue sampling for mechanical testing

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Supersonic Imagine Aixplorer SWE Ultrasound Imaging

Trial Overview The study is testing a new ultrasound technology called Supersonic Imagine Aixplorer SWE to measure the stiffness of uterine fibroid tissues non-invasively. It aims to see if this can predict how well medical therapies will work on these fibroids.

Participant Groups

Group I: Healthy Controls Experimental Treatment 1 Intervention

Women Supersonic Imagine Aixplorer SWE Ultrasound Imaging on two separate occasions.

Group II: FIB-Sx Experimental Treatment 1 Intervention

Women receiving Supersonic Imagine Aixplorer SWE Ultrasound Imaging prior to elective hysterectomy for treatment of symptomatic uterine fibroids.

Group III: FIB-Mx Experimental Treatment 1 Intervention

Women receiving Supersonic Imagine Aixplorer SWE Ultrasound Imaging prior to and at two points during elective medical therapy for treatment of symptomatic uterine fibroids.

Who Is Running the Clinical Trial?

Dr. Linda McLean

Lead Sponsor

Trials

1

Recruited

60+

Ottawa Hospital Research Institute

Collaborator

Trials

585

Recruited

3,283,000+

The Ottawa Hospital

Collaborator

Trials

97

Recruited

64,000+

Findings from Research

In a study involving 23,188 abdominal examinations using the ultrasound contrast agent SonoVue, only 29 adverse events (AEs) were reported, indicating a very low incidence of complications.

The overall rate of serious adverse events was extremely low at 0.0086%, and SonoVue demonstrated a good safety profile, comparable to or better than other contrast agents used in radiology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of Sonovue in abdominal applications: retrospective analysis of 23188 investigations. Piscaglia, F., Bolondi, L.[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 large retrospective analysis involving over 78,000 doses of ultrasound contrast agents (Definity and Optison), only 0.01% of patients experienced severe adverse reactions, indicating a strong safety profile for these agents.

The study found that severe reactions were primarily in outpatients, with no serious events reported in critically ill patients, suggesting that ultrasound contrast agents are safe for use in a variety of clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of deFinity and Optison for ultrasound image enhancement: a retrospective analysis of 78,383 administered contrast doses. Wei, K., Mulvagh, SL., Carson, L., et al.[2022]

Ultrasound contrast agents are generally safe for clinical use, with serious adverse reactions being rare and most adverse events being minor and self-resolving, such as headache and nausea.

The Contrast Media Safety Committee found that while intolerance to some components can occur, generalized allergy-like reactions are infrequent, emphasizing the overall well-tolerated nature of these agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of ultrasound contrast agents. Jakobsen, JA., Oyen, R., Thomsen, HS., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

The safety of Sonovue in abdominal applications: retrospective analysis of 23188 investigations. [2022]

2. 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]

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

The safety of deFinity and Optison for ultrasound image enhancement: a retrospective analysis of 78,383 administered contrast doses. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Safety of ultrasound contrast agents. [2020]

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

Adverse effect analysis of high-intensity focused ultrasound in the treatment of benign uterine diseases. [2019]

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

A retrospective study of ultrasound-guided high intensity focussed ultrasound ablation for multiple uterine fibroids in South Africa. [2019]

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

Magnetic resonance imaging-guided focused ultrasound treatment of symptomatic uterine fibroids: impact of technology advancement on ablation volumes in 115 patients. [2013]

8. Germany pubmed.ncbi.nlm.nih.gov

Portable ultrasound-guided high-intensity focused ultrasound with functions for safe and rapid ablation: prospective clinical trial for uterine fibroids-short-term and long-term results. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Reproducibility of the measurement of submucous fibroid protrusion into the uterine cavity using three-dimensional saline contrast sonohysterography. [2016]

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

Increased Speed and Image Quality for Pelvic Single-Shot Fast Spin-Echo Imaging with Variable Refocusing Flip Angles and Full-Fourier Acquisition. [2018]