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

Primary Purpose

Uterine Fibroid

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Contrast-enhancement ultrasound with Sonovue
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Uterine Fibroid focused on measuring MR-HIFU, HIFU, Fibroid treatment, MR Perfusion, CEUS perfusion, Diffusion weighted imaging, ARFI, Fibroid stiffness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Exclusion Criteria:

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

Sites / Locations

  • Service d'imagerie médicale

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient

Arm Description

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

Outcomes

Primary Outcome Measures

Ablathermy efficiency.
necrosis tumor volume / total volume ratio

Secondary Outcome Measures

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
Fibroid signal intensity ratio on T2.
Measurements of influence of fibroid signal intensity ratio on T2 on intraprocedural thermal parameters.
Fibroids perfusion data computed with MR perfusion
Comparison fibroids perfusion data computed with MR perfusion versus contrast-enhanced ultrasound.

Full Information

First Posted
February 18, 2015
Last Updated
November 9, 2017
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT02386137
Brief Title
Factors Influencing Volumetric MR-HIFU Ablation of Uterine Fibroids
Acronym
PERAGUS
Official Title
Volumetric MR-HIFU Ablation of Uterine Fibroids: Factors Influencing Intraprocedural Thermal Parameters
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
July 22, 2015 (Actual)
Primary Completion Date
October 31, 2017 (Actual)
Study Completion Date
October 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroid
Keywords
MR-HIFU, HIFU, Fibroid treatment, MR Perfusion, CEUS perfusion, Diffusion weighted imaging, ARFI, Fibroid stiffness

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient
Arm Type
Experimental
Arm Description
Woman aged more than 18 years having one or two symptomatic fibroid with size < 15cm.
Intervention Type
Device
Intervention Name(s)
Contrast-enhancement ultrasound with Sonovue
Primary Outcome Measure Information:
Title
Ablathermy efficiency.
Description
necrosis tumor volume / total volume ratio
Time Frame
2 months after inclusion
Secondary Outcome Measure Information:
Title
Thermal parameters
Description
Total duration of insonification Maximal temperature peak Cooling rate Efficient thermal dose Necrosis percentage Processing speed (necrosis volume / processing time) Transmitter/fibroma distance
Time Frame
2 months after inclusion
Title
Fibroid signal intensity ratio on T2.
Description
Measurements of influence of fibroid signal intensity ratio on T2 on intraprocedural thermal parameters.
Time Frame
At inclusion and 2 months after inclusion
Title
Fibroids perfusion data computed with MR perfusion
Description
Comparison fibroids perfusion data computed with MR perfusion versus contrast-enhanced ultrasound.
Time Frame
At inclusion

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine BENARD, MD
Organizational Affiliation
University Hospital Bordeaux, France
Official's Role
Study Chair
Facility Information:
Facility Name
Service d'imagerie médicale
City
Bordeaux
ZIP/Postal Code
33000
Country
France

12. IPD Sharing Statement

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Factors Influencing Volumetric MR-HIFU Ablation of Uterine Fibroids

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