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Completed

NCT Number: NCT04345003

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

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

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Key information

Conditions

Uterine Fibroid Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU Bordeaux

Bordeaux, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Myoma elastography

Device

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.

Primary outcomes

  1. Composite criteria

    Time frame: Baseline

    Composite criteria measured from:

    • myoma stiffness (measured by Resoundant system) and
    • ablathermy efficiency.

Secondary outcomes

  1. leiomyoma stiffness measured by Resoundant system

    Time frame: Baseline

    leiomyoma stiffness measured by Resoundant system

  2. leiomyoma stiffness measured by ARFI-US

    Time frame: Baseline

    leiomyoma stiffness measured by ARFI-US

  3. clinical efficiency

    Time frame: month 6

    Defined as a decrease of 10pts on UFS-Qol score

  4. inter-observer reproducibility

    Time frame: Baseline

    inter-observer reproducibility of leiomyoma stiffness measurements by Resoundant system

  5. leiomyoma perfusion

    Time frame: Month 6

    leiomyoma perfusion (diffusion)

  6. leiomyoma T2 signal

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: ELASTUS

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 14, 2020
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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