Factors Influencing Volumetric MR-HIFU Ablation of Uterine Fibroids (PERAGUS)

November 9, 2017 updated by: University Hospital, Bordeaux

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33000
        • Service d'Imagerie Medicale

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ablathermy efficiency.
Time Frame: 2 months after inclusion
necrosis tumor volume / total volume ratio
2 months after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thermal parameters
Time Frame: 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
2 months after inclusion
Fibroid signal intensity ratio on T2.
Time Frame: At inclusion and 2 months after inclusion
Measurements of influence of fibroid signal intensity ratio on T2 on intraprocedural thermal parameters.
At inclusion and 2 months after inclusion
Fibroids perfusion data computed with MR perfusion
Time Frame: At inclusion
Comparison fibroids perfusion data computed with MR perfusion versus contrast-enhanced ultrasound.
At inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 22, 2015

Primary Completion (ACTUAL)

October 31, 2017

Study Completion (ACTUAL)

October 31, 2017

Study Registration Dates

First Submitted

February 18, 2015

First Submitted That Met QC Criteria

March 10, 2015

First Posted (ESTIMATE)

March 11, 2015

Study Record Updates

Last Update Posted (ACTUAL)

November 13, 2017

Last Update Submitted That Met QC Criteria

November 9, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2014/05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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