PERAGUS: Factors Influencing Volumetric MR-HIFU Ablation of Uterine Fibroids

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Completed

CT.gov ID

NCT02386137

Collaborator

(none)

Enrollment

Location

Arm

27.3

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Uterine Fibroid	Device: Contrast-enhancement ultrasound with Sonovue	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Volumetric MR-HIFU Ablation of Uterine Fibroids: Factors Influencing Intraprocedural Thermal Parameters

Actual Study Start Date :

Jul 22, 2015

Actual Primary Completion Date :

Oct 31, 2017

Actual Study Completion Date :

Oct 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patient Woman aged more than 18 years having one or two symptomatic fibroid with size < 15cm.	Device: Contrast-enhancement ultrasound with Sonovue

Arm

Intervention/Treatment

Experimental: Patient

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

Device: Contrast-enhancement ultrasound with Sonovue

Outcome Measures

Primary Outcome Measures

Ablathermy efficiency. [2 months after inclusion]
necrosis tumor volume / total volume ratio

Secondary Outcome Measures

Thermal parameters [2 months after inclusion]
Total duration of insonification Maximal temperature peak Cooling rate Efficient thermal dose Necrosis percentage Processing speed (necrosis volume / processing time) Transmitter/fibroma distance
Fibroid signal intensity ratio on T2. [At inclusion and 2 months after inclusion]
Measurements of influence of fibroid signal intensity ratio on T2 on intraprocedural thermal parameters.
Fibroids perfusion data computed with MR perfusion [At inclusion]
Comparison fibroids perfusion data computed with MR perfusion versus contrast-enhanced ultrasound.

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.
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