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Factors Influencing Volumetric MR-HIFU Ablation of Uterine Fibroids

NCT02386137 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-14

No results posted yet for this study

Summary

Magnetic resonance (MR)-guided high-intensity focused ultrasound (HIFU) ablation is increasingly being used worldwide to treat symptomatic uterine fibroids because of its excellent therapeutic efficacy in controlling symptoms and its excellent safety record. Despite the benefits, it should be recognized that MR HIFU ablation does not always yield good therapeutic outcomes. High signal intensity on T2-weighted MR images and a high volume transfer constant (or Ktrans) on dynamic contrast material-enhanced MR images are the most well-known risk factors for poor ablation outcomes as measured with the non-perfused volume (NPV) ratio (ie, NPV divided by fibroid volume).

The aim of this study is to assess the influence of fibroid perfusion (evaluated by MRI and contrast enhanced ultrasound), apparent diffusion coefficient (evaluated by MR-diffusion imaging) and fibroid stiffness (evaluated by ARFI) on ablation efficiency during uterine fibroid treatment by MR-HIFU.

Conditions

  • Uterine Fibroid

Interventions

DEVICE

Contrast-enhancement ultrasound with Sonovue

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Antoine BENARD, MD · University Hospital Bordeaux, France

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-22
Primary Completion
2017-10-31
Completion
2017-10-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02386137 on ClinicalTrials.gov