MR Elastography Parameters Impact on MR-HIFU Efficacy in Uterine Fibroids

Uterine Fibroid Clinical Trial

— ELASTUS  

Official title:

MR Elastography Parameters Impact on MR-HIFU Efficacy in Uterine Fibroids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04345003
• Other study ID #: CHUBX 2018/35
• Status: Completed
• Phase: N/A
• Start date: June 18, 2020
• Est. completion date: August 31, 2023

Study information

• Verified date: December 2023
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 31, 2023
• Est. primary completion date: February 21, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroid

Intervention

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.

Locations

Country	Name	City	State
France	CHU Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite criteria	Composite criteria measured from: myoma stiffness (measured by Resoundant system) and; ablathermy efficiency.	Baseline
Secondary	leiomyoma stiffness measured by Resoundant system	leiomyoma stiffness measured by Resoundant system	Baseline
Secondary	leiomyoma stiffness measured by ARFI-US	leiomyoma stiffness measured by ARFI-US	Baseline
Secondary	clinical efficiency	Defined as a decrease of 10pts on UFS-Qol score	month 6
Secondary	inter-observer reproducibility	inter-observer reproducibility of leiomyoma stiffness measurements by Resoundant system	Baseline
Secondary	leiomyoma perfusion	leiomyoma perfusion (diffusion)	Month 6
Secondary	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