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临床试验/NCT03369600
NCT03369600Enrolling By Invitation不适用

Characterisation of Tissue Stiffness to Improve the Diagnosis and Management of Uterine Fibroids

Dr. Linda McLean2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年8月17日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
60
试验地点
2
主要终点
In vivo Tissue Stiffness

研究概览

简要总结

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.

详细描述

Aims and Objectives The goal of this project is to understand if and how uterine fibroid tissue stiffness, measured by SWE, can be used to predict and monitor response to medical therapy in patients with symptomatic uterine fibroids.

Aim 1: To assess the feasibility of using SWE for measuring stiffness of non-neoplastic myometrium and uterine fibroid tissue in pre-menopausal women Objective 1.1: Assess the inter- and intra-session reliability of measuring uterine tissue stiffness with SWE in 60 women with uterine fibroids and 60 healthy matched control participants.

Objective 1.2: Using data acquired from the 60 women with uterine fibroids, the validity of SWE will be assessed by comparing in vivo uterine tissue stiffness measured by SWE to the stiffness of surgically excised uterine tissue samples measured ex vivo by a mechanical tester.

Objective 1.3: To assess the confounding effect of age, parity, contraceptive use, and presence of fibroids on myometrial stiffness measured by SWE in 60 women with uterine fibroids and 60 healthy matched control participants.

Aim 2: To assess the clinical applicability of using tissue stiffness measured by SWE for the classification and monitoring of uterine fibroids in pre-menopausal women.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

In vivo Tissue Stiffness

时间窗: 2 years

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

次要结局

  • Ex vivo Tissue Stiffness(2 years)
  • SWE Validity(2 years)
  • SWE Reliability(2 years)

研究者

发起方
Dr. Linda McLean
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Linda McLean

Co-Investigator

University of Ottawa

研究点 (2)

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