NCT03369600

Characterisation of Uterine Fibroid Tissue Stiffness

Status unknown NA Last updated 10 May 2023

What this trial tests

NA trial testing Supersonic Imagine Aixplorer SWE Ultrasound Imaging in Leiomyoma in 60 participants. Status unknown.

Timeline

17 August 2018

Primary endpoint
31 July 2024

31 July 2025

Quick facts

Lead sponsor	Dr. Linda McLean
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	health services research
Enrollment	60
Start date	17 August 2018
Primary completion	31 July 2024
Estimated completion	31 July 2025
Sites	1 location across Canada

Drugs / interventions tested

• Supersonic Imagine Aixplorer SWE Ultrasound Imaging

Conditions studied

• Leiomyoma — all drugs for Leiomyoma →

Sponsor

Dr. Linda McLean

Who can join

Adults 18 to 80, female only, with Leiomyoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.