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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new type of ultrasound imaging can predict the effectiveness of medical treatments for women with uterine fibroids. Uterine fibroids are non-cancerous growths in the uterus that can cause issues like heavy bleeding or pain. The study uses shear wave elastography, a technology that measures tissue stiffness, to determine which fibroids might respond better to medication. Premenopausal women with fibroids confirmed by imaging who plan to undergo treatment for symptoms may be suitable candidates. The goal is to improve treatment plans and outcomes for those dealing with fibroids. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance future treatment strategies.

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.

What prior data suggests that this ultrasound imaging technique is safe for use in gynecology?

Research has shown that the Supersonic Imagine Aixplorer SWE Ultrasound Imaging is generally easy for patients to handle. This type of ultrasound is already used in healthcare, particularly for assessing liver health. It measures tissue stiffness without causing harm. Studies have not identified any major side effects with this imaging tool.

In another study, this ultrasound examined conditions in the uterus. The results revealed no major safety issues. The technology aids doctors in predicting the effectiveness of treatments for uterine fibroids without adding risk to patients. Overall, evidence suggests this tool is safe for use in medical settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using the Supersonic Imagine Aixplorer SWE Ultrasound Imaging for fibroids because it offers a non-invasive way to assess fibroid characteristics and monitor treatment progress. Unlike standard methods like MRIs or CT scans, this ultrasound technique provides real-time imaging with the added benefit of measuring tissue stiffness, which can be crucial for evaluating fibroid response to therapies. This approach could lead to more personalized and timely treatment decisions, potentially improving outcomes for women with symptomatic fibroids.

What evidence suggests that this ultrasound imaging technique is effective for assessing uterine fibroids?

This trial will use Supersonic Imagine Aixplorer SWE Ultrasound Imaging to study uterine fibroids. Research has shown that shear wave elastography (SWE), the technology used in this trial, can measure the stiffness of uterine fibroids. SWE has already proven useful in conditions like adenomyosis, where it measures increased stiffness in affected tissues. Early findings suggest that SWE can identify fibroids with varying stiffness levels, potentially influencing their response to treatments. This technology could help doctors predict which fibroids might respond better to certain therapies. Understanding these tissue properties is crucial for improving treatment plans for women with uterine fibroids. ^{1 3 4 6 7}

Who Is on the Research Team?

Linda McLean, PhD

Principal Investigator

University of Ottawa

Sukhbir S Singh, MD, FRCSC

Principal Investigator

The Ottawa Hospital Research Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

Citations

1.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT03369600/characterisation-of-uterine-fibroid-tissue-stiffness

Characterisation of Uterine Fibroid Tissue Stiffness

Primary Treatment: Supersonic Imagine Aixplorer SWE Ultrasound Imaging ... SWE in 60 women with uterine fibroids and 60 healthy matched ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5098712/

Value of ultrasound shear wave elastography in ...

This study showed a significant increase of the myometrial stiffness estimated with shear wave elastography use in patients with adenomyosis.

3.

mayo.edu

mayo.edu/research/clinical-trials/tests-procedures/ultrasound

Ultrasound Clinical Trials

The purpose of this study is to evaluate the safety and ablation efficacy of the ExAblate UF V2 System when treating symptomatic uterine fibroids. The ExAblate ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/28341490/

Validation of Shear Wave Elastography Cutoff Values on the ...

The purpose of this study was to determine the validity of previously established ultrasound shear wave elastography (SWE) cut-off values (≥F2 fibrosis) on an ...

5.

researchgate.net

researchgate.net/figure/Vs-measured-in-the-uterine-leiomyosarcoma-a-and-leiomyoma-b-Significant-differences_fig2_263899154

Vs measured in the uterine leiomyosarcoma (a) and ...

Shear wave elastography (SWE) was used to dynamically monitor myometrial elasticity changes in patients before and after surgery. Moreover, our study monitored ...

6.

insightsimaging.springeropen.com

insightsimaging.springeropen.com/articles/10.1186/s13244-020-0841-4

Assessment of early damage of endometrium after artificial ...

Supersonic Imagine AixPlorer ultrasonic instrument with SWE (Shear WaveTM) was used for the detection of endometrial elasticity. The SE12-3 ...

7.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf24/K242223.pdf

SuperSonic Imagine Charlotte Turc Official Correspondent ...

The SuperSonic Imagine® SuperSonic® HepaVu™ systems are cart based ultrasound imaging systems used to perform ... ultrasound data and to display ...