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Factors Influencing Volumetric MR-HIFU Ablation of Uterine Fibroids

NCT ID: NCT02386137

Last Updated: 2017-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-22

Study Completion Date

2017-10-31

Brief Summary

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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.

Detailed Description

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Preprocedural predictors of treatment efficacy will be useful for excluding in advance patients who would not benefit from this treatment, thereby contributing to improved overall clinical outcomes. During ablathermy treatment lost of energy depend of tissue perfusion and thermic diffusion while energy laying depend of tissue absorption coefficient. Study these parameters before treatment could bring important information to the treatment difficulty and its efficacy. The investigators will study and compare fibroid perfusion with dynamic contrast-enhanced magnetic resonance imaging and contrast-enhanced ultrasound (CEUS). CEUS will be performed with contrast agent (SONOVUE). Thermic diffusion could be linked with fibroid stiffness. Fibroid stiffness will be quantified with velocity of shear wave measured by acoustic radiation force impulse (ARFI). Tissue absorption coefficient is correlated with the architecture and the cellularity of the tissue so the investigators think that apparent diffusion coefficient (computed with diffusion weighted imaging) could be correlated with ablathermy efficiency and other intra procedural thermal parameters.

Conditions

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Uterine Fibroid

Keywords

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MR-HIFU HIFU Fibroid treatment MR Perfusion CEUS perfusion Diffusion weighted imaging ARFI Fibroid stiffness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patient

Woman aged more than 18 years having one or two symptomatic fibroid with size \< 15cm.

Group Type EXPERIMENTAL

Contrast-enhancement ultrasound with Sonovue

Intervention Type DEVICE

Interventions

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Contrast-enhancement ultrasound with Sonovue

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Woman
* Aged more than 18 years
* Not postmenopausal
* Having one or two symptomatic fibroid with size \< 15cm.
* Symptoms Severity Score (SSS) score on Uterine Fibroid Symptoms related Quality of Life (UFS-Qol) ≥ 10
* Signed informed consent prior to any study related procedure
* With a medical insurance

Exclusion Criteria

* Contraindicated to MR examination, SONOVUE and gadolinium contrast injection (pregnancy etc..).
* Presence or suspicious of pelvic malignant tumor
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antoine BENARD, MD

Role: STUDY_CHAIR

University Hospital Bordeaux, France

Locations

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Service d'imagerie médicale

Bordeaux, , France

Site Status

Countries

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France

Other Identifiers

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CHUBX 2014/05

Identifier Type: -

Identifier Source: org_study_id