MR Elastography Parameters Impact on MR-HIFU Efficacy in Uterine Fibroids (ELASTUS)

Magnetic resonance (MR)-guided high-intensity focused ultrasound (HIFU) ablation for fibroids is an outpatient approach for controlling symptom with an excellent safety record. It is important to exclude in advance patients who would not benefit from this treatment. For that purpose this study assesses the influence of fibroid elasticity and diffusion on ablation efficiency during treatment by MR-HIFU

Study Overview

• Status: Completed
• Conditions: Uterine Fibroid
• Intervention / Treatment: Device: Myoma elastography

Detailed Description

Pre-procedural predictors of treatment efficacy will be useful for excluding in advance patients who would not get benefit of this treatment. It seems that elastography, cellular density and perfusion could be considered as predictors. Fibroid elastography will be quantified by MRE Resoundant® system and pelvic ultrasound. Perfusion and cellular density will be quantified by MR diffusion.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France
    • CHU Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Woman
• Aged more than 18 years
• Not postmenopausal
• Having one or two symptomatic fibroid with size < 15cm.
• Leiomyoma type Funaki 1 or 2 on pre-therapeutic MRI
• Normal cervicovaginal smear performed within 2 years prior to inclusion
• Myoma technically accessible to MR-HIFU treatment verified on pre-therapeutic MRI
• SSS score on UFS-Qol ≥ 10
• Signed informed consent prior to any study related procedure
• With a medical insurance

Exclusion Criteria:

• Contraindicated to MR examination, gadolinium contrast injection (pregnancy etc..).
• Presence or suspicious of pelvic malignant tumor
• Myomas causing haemorrhage (meno-metrorrhagia) associated with anemia (Hb <10g/dl)
• Pregnant or lactating woman
• Small submucous myoma accessible for hysteroscopic treatment.
• Active pelvic infection
• Presence of calcification, surgical staples, or rigid implant in the passage of the ultrasound beamo People placed under legal protection, or participating in another research protocol including an exclusion period still in progress at pre-inclusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Myoma elastography; The standard pre-therapeutic assessment includes a pelvic US to eliminate the presence of calcification of fibroids. If this absence is confirmed, the elasticity of uterine myoma (by ARFI method) will be measured. The standard pre-therapeutic MRI performed allows to classify and measure the myoma in order to determine if it is accessible for HIFU treatment. MRI elastography sequence with the Resoundant® system will be performed during this exam.

Device: Myoma elastography; The standard pre-therapeutic assessment includes a pelvic US to eliminate the presence of calcification of fibroids. If this absence is confirmed, the elasticity of uterine myoma (by ARFI method) will be measured. The standard pre-therapeutic MRI performed allows to classify and measure the myoma in order to determine if it is accessible for HIFU treatment. MRI elastography sequence with the Resoundant® system will be performed during this exam.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite criteria	Composite criteria measured from: myoma stiffness (measured by Resoundant system) and; ablathermy efficiency.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
leiomyoma stiffness measured by Resoundant system	leiomyoma stiffness measured by Resoundant system	Baseline
leiomyoma stiffness measured by ARFI-US	leiomyoma stiffness measured by ARFI-US	Baseline
clinical efficiency	Defined as a decrease of 10pts on UFS-Qol score	month 6
inter-observer reproducibility	inter-observer reproducibility of leiomyoma stiffness measurements by Resoundant system	Baseline
leiomyoma perfusion	leiomyoma perfusion (diffusion)	Month 6
leiomyoma T2 signal	It will be evaluated in two ways: The first consists of a qualitative analysis taking as a reference the signal of the paravertebral muscles. Myomas will then be classified into a hypersignal, iso-signal or hyposignal group as compared to muscles (qualitative method according to the classification of Funaki). The second will be a quantitative method. One ROI will be positioned in the myoma and a second in the paravertebral muscle and the ratio of these values will be recorded.	Month 6

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2020
• Primary Completion (Actual): February 21, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: March 16, 2020
• First Submitted That Met QC Criteria: April 9, 2020
• First Posted (Actual): April 14, 2020

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: HIFU; Diffusion weighted imaging; Perfusion; Fibroid treatment; MR elastography; ARFI; Fibroid stiffness
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Neoplasms, Muscle Tissue; Leiomyoma
• Other Study ID Numbers: CHUBX 2018/35; 2019-A02963-54 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No