Clinical trial NCT02386137: Factors Influencing Volumetric MR-HIFU Ablation of Uterine Fibroids
Official title: Volumetric MR-HIFU Ablation of Uterine Fibroids: Factors Influencing Intraprocedural Thermal Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Fibroid
Keywords: MR-HIFU
HIFU
Fibroid treatment
MR Perfusion
CEUS perfusion
Diffusion weighted imaging
ARFI
Fibroid stiffness
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2015-03-11
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ablathermy efficiency.
timeFrame: 2 months after inclusion
Secondary outcomes:
measure: Thermal parameters
timeFrame: 2 months after inclusion
measure: Fibroid signal intensity ratio on T2.
timeFrame: At inclusion and 2 months after inclusion
measure: Fibroids perfusion data computed with MR perfusion
timeFrame: At inclusion
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Service d'imagerie médicale
Study officials:
affiliation: University Hospital Bordeaux, France
name: Antoine BENARD, MD
role: STUDY_CHAIR
References: