Factors Influencing Volumetric MR-HIFU Ablation of Uterine Fibroids

Uterine Fibroid Clinical Trial

— PERAGUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02386137
• Other study ID #: CHUBX 2014/05
• Status: Completed
• Phase: N/A
• First received: February 18, 2015
• Last updated: November 9, 2017
• Start date: July 22, 2015
• Est. completion date: October 31, 2017

Study information

• Verified date: November 2017
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroid

Intervention

Device:
• Contrast-enhancement ultrasound with Sonovue

Locations

Country	Name	City	State
France	Service d'imagerie médicale	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ablathermy efficiency.	necrosis tumor volume / total volume ratio	2 months after inclusion
Secondary	Thermal parameters	Total duration of insonification Maximal temperature peak Cooling rate Efficient thermal dose Necrosis percentage Processing speed (necrosis volume / processing time) Transmitter/fibroma distance	2 months after inclusion
Secondary	Fibroid signal intensity ratio on T2.	Measurements of influence of fibroid signal intensity ratio on T2 on intraprocedural thermal parameters.	At inclusion and 2 months after inclusion
Secondary	Fibroids perfusion data computed with MR perfusion	Comparison fibroids perfusion data computed with MR perfusion versus contrast-enhanced ultrasound.	At inclusion