Characterisation of Uterine Fibroid Tissue Stiffness

Summary

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.

Conditions

• Leiomyoma

Interventions

DEVICE

Supersonic Imagine Aixplorer SWE Ultrasound Imaging

Consented women will attend 2+ sessions where they will be imaged using the Supersonic Imagine Aixplorer for Shear Wave Elastography imaging.

Sponsors & Collaborators

• Ottawa Hospital Research Institute

  collaborator OTHER

• The Ottawa Hospital

  collaborator OTHER

• Dr. Linda McLean

  lead OTHER

Principal Investigators

• Linda McLean, PhD · University of Ottawa

• Sukhbir S Singh, MD, FRCSC · The Ottawa Hospital Research Institute

Study Design

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-08-17

Primary Completion

2024-07-31

Completion

2025-07-31

Countries

• Canada

Study Locations