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

University Hospital of Bordeaux

Status: Completed

Conditions: Uterine Fibroid

Treatments: Device: Myoma elastography

Study type: Interventional

Funder types: Other

Identifiers

NCT04345003

CHUBX 2018/35

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Myoma elastography

Experimental group

Description:

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.

Treatment:

Device: Myoma elastography