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

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Recruiting

CT.gov ID

NCT04345003

Collaborator

(none)

Enrollment

Location

Arm

30.9

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Uterine Fibroid	Device: Myoma elastography	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 18, 2020

Anticipated Primary Completion Date :

Jan 15, 2023

Anticipated Study Completion Date :

Jan 15, 2023

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Composite criteria [Baseline]
Composite criteria measured from: myoma stiffness (measured by Resoundant system) and ablathermy efficiency.

Secondary Outcome Measures

leiomyoma stiffness measured by Resoundant system [Baseline]
leiomyoma stiffness measured by Resoundant system
leiomyoma stiffness measured by ARFI-US [Baseline]
leiomyoma stiffness measured by ARFI-US
clinical efficiency [month 6]
Defined as a decrease of 10pts on UFS-Qol score
inter-observer reproducibility [Baseline]
inter-observer reproducibility of leiomyoma stiffness measurements by Resoundant system
leiomyoma perfusion [Month 6]
leiomyoma perfusion (diffusion)
leiomyoma T2 signal [Month 6]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.