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MR Elastography Parameters Impact on MR-HIFU Efficacy in Uterine Fibroids (ELASTUS)

Primary Purpose

Uterine Fibroid

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Myoma elastography
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Fibroid focused on measuring HIFU, Fibroid treatment, MR elastography, 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.
  • Leiomyoma type Funaki 1 or 2 on pre-therapeutic MRI
  • Normal cervicovaginal smear performed within 2 years prior to inclusion
  • Myoma technically accessible to MR-HIFU treatment verified on pre-therapeutic MRI
  • SSS score on UFS-Qol ≥ 10
  • Signed informed consent prior to any study related procedure
  • With a medical insurance

Exclusion Criteria:

  • Contraindicated to MR examination, gadolinium contrast injection (pregnancy etc..).
  • Presence or suspicious of pelvic malignant tumor
  • Myomas causing haemorrhage (meno-metrorrhagia) associated with anemia (Hb <10g/dl)
  • Pregnant or lactating woman
  • Small submucous myoma accessible for hysteroscopic treatment.
  • Active pelvic infection
  • Presence of calcification, surgical staples, or rigid implant in the passage of the ultrasound beamo People placed under legal protection, or participating in another research protocol including an exclusion period still in progress at pre-inclusion.

Sites / Locations

  • CHU Bordeaux

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Myoma elastography

Arm Description

The standard pre-therapeutic assessment includes a pelvic US to eliminate the presence of calcification of fibroids. If this absence is confirmed, the elasticity of uterine myoma (by ARFI method) will be measured. The standard pre-therapeutic MRI performed allows to classify and measure the myoma in order to determine if it is accessible for HIFU treatment. MRI elastography sequence with the Resoundant® system will be performed during this exam.

Outcomes

Primary Outcome Measures

Composite criteria
Composite criteria measured from: myoma stiffness (measured by Resoundant system) and ablathermy efficiency.

Secondary Outcome Measures

leiomyoma stiffness measured by Resoundant system
leiomyoma stiffness measured by Resoundant system
leiomyoma stiffness measured by ARFI-US
leiomyoma stiffness measured by ARFI-US
clinical efficiency
Defined as a decrease of 10pts on UFS-Qol score
inter-observer reproducibility
inter-observer reproducibility of leiomyoma stiffness measurements by Resoundant system
leiomyoma perfusion
leiomyoma perfusion (diffusion)
leiomyoma T2 signal
It will be evaluated in two ways: The first consists of a qualitative analysis taking as a reference the signal of the paravertebral muscles. Myomas will then be classified into a hypersignal, iso-signal or hyposignal group as compared to muscles (qualitative method according to the classification of Funaki). The second will be a quantitative method. One ROI will be positioned in the myoma and a second in the paravertebral muscle and the ratio of these values will be recorded.

Full Information

First Posted
March 16, 2020
Last Updated
April 27, 2023
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT04345003
Brief Title
MR Elastography Parameters Impact on MR-HIFU Efficacy in Uterine Fibroids
Acronym
ELASTUS
Official Title
MR Elastography Parameters Impact on MR-HIFU Efficacy in Uterine Fibroids
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 18, 2020 (Actual)
Primary Completion Date
July 15, 2023 (Anticipated)
Study Completion Date
July 15, 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Magnetic resonance (MR)-guided high-intensity focused ultrasound (HIFU) ablation for fibroids is an outpatient approach for controlling symptom with an excellent safety record. It is important to exclude in advance patients who would not benefit from this treatment. For that purpose this study assesses the influence of fibroid elasticity and diffusion on ablation efficiency during treatment by MR-HIFU
Detailed Description
Pre-procedural predictors of treatment efficacy will be useful for excluding in advance patients who would not get benefit of this treatment. It seems that elastography, cellular density and perfusion could be considered as predictors. Fibroid elastography will be quantified by MRE Resoundant® system and pelvic ultrasound. Perfusion and cellular density will be quantified by MR diffusion.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
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
Myoma elastography
Arm Type
Experimental
Arm Description
The standard pre-therapeutic assessment includes a pelvic US to eliminate the presence of calcification of fibroids. If this absence is confirmed, the elasticity of uterine myoma (by ARFI method) will be measured. The standard pre-therapeutic MRI performed allows to classify and measure the myoma in order to determine if it is accessible for HIFU treatment. MRI elastography sequence with the Resoundant® system will be performed during this exam.
Intervention Type
Device
Intervention Name(s)
Myoma elastography
Intervention Description
The standard pre-therapeutic assessment includes a pelvic US to eliminate the presence of calcification of fibroids. If this absence is confirmed, the elasticity of uterine myoma (by ARFI method) will be measured. The standard pre-therapeutic MRI performed allows to classify and measure the myoma in order to determine if it is accessible for HIFU treatment. MRI elastography sequence with the Resoundant® system will be performed during this exam.
Primary Outcome Measure Information:
Title
Composite criteria
Description
Composite criteria measured from: myoma stiffness (measured by Resoundant system) and ablathermy efficiency.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
leiomyoma stiffness measured by Resoundant system
Description
leiomyoma stiffness measured by Resoundant system
Time Frame
Baseline
Title
leiomyoma stiffness measured by ARFI-US
Description
leiomyoma stiffness measured by ARFI-US
Time Frame
Baseline
Title
clinical efficiency
Description
Defined as a decrease of 10pts on UFS-Qol score
Time Frame
month 6
Title
inter-observer reproducibility
Description
inter-observer reproducibility of leiomyoma stiffness measurements by Resoundant system
Time Frame
Baseline
Title
leiomyoma perfusion
Description
leiomyoma perfusion (diffusion)
Time Frame
Month 6
Title
leiomyoma T2 signal
Description
It will be evaluated in two ways: The first consists of a qualitative analysis taking as a reference the signal of the paravertebral muscles. Myomas will then be classified into a hypersignal, iso-signal or hyposignal group as compared to muscles (qualitative method according to the classification of Funaki). The second will be a quantitative method. One ROI will be positioned in the myoma and a second in the paravertebral muscle and the ratio of these values will be recorded.
Time Frame
Month 6

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. Leiomyoma type Funaki 1 or 2 on pre-therapeutic MRI Normal cervicovaginal smear performed within 2 years prior to inclusion Myoma technically accessible to MR-HIFU treatment verified on pre-therapeutic MRI SSS score on UFS-Qol ≥ 10 Signed informed consent prior to any study related procedure With a medical insurance Exclusion Criteria: Contraindicated to MR examination, gadolinium contrast injection (pregnancy etc..). Presence or suspicious of pelvic malignant tumor Myomas causing haemorrhage (meno-metrorrhagia) associated with anemia (Hb <10g/dl) Pregnant or lactating woman Small submucous myoma accessible for hysteroscopic treatment. Active pelvic infection Presence of calcification, surgical staples, or rigid implant in the passage of the ultrasound beamo People placed under legal protection, or participating in another research protocol including an exclusion period still in progress at pre-inclusion.
Facility Information:
Facility Name
CHU Bordeaux
City
Bordeaux
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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MR Elastography Parameters Impact on MR-HIFU Efficacy in Uterine Fibroids

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