Clinical trial · Interventional
Characterisation of Uterine Fibroid Tissue Stiffness
Characterisation of Tissue Stiffness to Improve the Diagnosis and Management of Uterine Fibroids
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leiomyoma | Leiomyoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Supersonic Imagine Aixplorer SWE Ultrasound Imaging | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Healthy Controls
- description
- Women Supersonic Imagine Aixplorer SWE Ultrasound Imaging on two separate occasions.
- interventionNames
- Device: Supersonic Imagine Aixplorer SWE Ultrasound Imaging
- type
- EXPERIMENTAL
- label
- FIB-Sx
- description
- Women receiving Supersonic Imagine Aixplorer SWE Ultrasound Imaging prior to elective hysterectomy for treatment of symptomatic uterine fibroids.
- interventionNames
- Device: Supersonic Imagine Aixplorer SWE Ultrasound Imaging
- type
- EXPERIMENTAL
- label
- FIB-Mx
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available