Characterisation of Uterine Fibroid Tissue Stiffness

NCT03369600 | Unknown

• 1 other identifier: Protocol # 20170872-01H
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

elastography

Outcome Measures

Primary Outcomes (1)

• In vivo Tissue Stiffness

  Tissue stiffness measured by shear wave elastography and reported in kilopascals and m/s

  2 years

Secondary Outcomes (3)

• Ex vivo Tissue Stiffness

  2 years

• SWE Validity

  2 years

• SWE Reliability

  2 years

Study Arms (3)

Healthy Controls

EXPERIMENTAL

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

Device: Supersonic Imagine Aixplorer SWE Ultrasound Imaging

FIB-Sx

EXPERIMENTAL

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

Device: Supersonic Imagine Aixplorer SWE Ultrasound Imaging

FIB-Mx

EXPERIMENTAL

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

Device: Supersonic Imagine Aixplorer SWE Ultrasound Imaging

Interventions

Supersonic Imagine Aixplorer SWE Ultrasound Imaging DEVICE

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

FIB-Mx; FIB-Sx; Healthy Controls

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Premenopausal
• No co-morbidities known to impact tissue properties
• Diagnosis of fibroids by imaging (FIB-Mx and FIB-Sx groups)
• Scheduled to undergo hysterectomy (FIB-Sx) or medical therapy (FIB-Mx) to treat symptomatic uterine fibroids
• \<6 fibroids identified by medical imaging
• no known history of gynecological pathologies
• regular menstrual cycles

You may not qualify if:

• confirmed or suspected uterine cancer
• pregnancy
• \<6months post-partum
• history of caesarean delivery
• previous uterine surgery

Sponsors & Collaborators

• Dr. Linda McLean: lead
• Ottawa Hospital Research Institute: collaborator
• The Ottawa Hospital: collaborator

Study Sites (1)

University of Ottawa, Motor Function Measurement Laboratory

Ottawa, Ontario, K1N 6N5, Canada

Location

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Linda McLean, PhD

  University of Ottawa

  PRINCIPAL INVESTIGATOR

• Sukhbir S Singh, MD, FRCSC

  The Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Investigator

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 12, 2017
• Study Start: August 17, 2018
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2025
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)