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Search / Trial NCT03369600

Characterisation of Uterine Fibroid Tissue Stiffness

Launched by DR. LINDA MCLEAN · Dec 8, 2017

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

Elastography

ClinConnect Summary

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 d...

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria (All Participants)
  • Age 18 or older
  • Premenopausal
  • No co-morbidities known to impact tissue properties
  • Inclusion (FIB-Sx and FIB-Mx groups)
  • 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
  • Inclusion (CON group)
  • no known history of gynecological pathologies
  • regular menstrual cycles
  • Exclusion Criteria (All Participants)
  • confirmed or suspected uterine cancer
  • pregnancy
  • \<6months post-partum
  • history of caesarean delivery
  • previous uterine surgery

About Dr. Linda Mclean

Dr. Linda McLean is an esteemed clinical trial sponsor with a robust background in medical research and patient care. With a focus on advancing innovative therapies and improving clinical outcomes, Dr. McLean leads multidisciplinary teams in the design and execution of clinical trials across various therapeutic areas. Her commitment to ethical research practices and patient safety ensures that all trials are conducted with the highest standards of integrity and compliance. Dr. McLean's extensive experience in both academia and industry positions her as a key contributor to the advancement of medical science and the development of new treatment options.

Locations

Ottawa, Ontario, Canada

Patients applied

0 patients applied

Trial Officials

Linda McLean, PhD

Principal Investigator

University of Ottawa

Sukhbir S Singh, MD, FRCSC

Principal Investigator

The Ottawa Hospital Research Institute

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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