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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04345003
Recruitment Status : Recruiting
First Posted : April 14, 2020
Last Update Posted : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

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

Condition or disease Intervention/treatment Phase
Uterine Fibroid Device: Myoma elastography Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MR Elastography Parameters Impact on MR-HIFU Efficacy in Uterine Fibroids
Actual Study Start Date : June 18, 2020
Estimated Primary Completion Date : January 15, 2023
Estimated Study Completion Date : January 15, 2023

Arm Intervention/treatment
Experimental: Myoma elastography

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.

Device: Myoma elastography

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 Measures :
  1. Composite criteria [ Time Frame: Baseline ]

    Composite criteria measured from:

    • myoma stiffness (measured by Resoundant system) and
    • ablathermy efficiency.


Secondary Outcome Measures :
  1. leiomyoma stiffness measured by Resoundant system [ Time Frame: Baseline ]
    leiomyoma stiffness measured by Resoundant system

  2. leiomyoma stiffness measured by ARFI-US [ Time Frame: Baseline ]
    leiomyoma stiffness measured by ARFI-US

  3. clinical efficiency [ Time Frame: month 6 ]
    Defined as a decrease of 10pts on UFS-Qol score

  4. inter-observer reproducibility [ Time Frame: Baseline ]
    inter-observer reproducibility of leiomyoma stiffness measurements by Resoundant system

  5. leiomyoma perfusion [ Time Frame: Month 6 ]
    leiomyoma perfusion (diffusion)

  6. leiomyoma T2 signal [ Time Frame: Month 6 ]

    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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04345003


Contacts
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Contact: Adrien Rateau, MD +33556795800 adrien.rateau@chu-bordeaux.fr
Contact: Hervé Trillaud, MD, PhD +33556795800 herve.trillaud@chu-bordeaux.fr

Locations
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France
CHU Bordeaux Recruiting
Bordeaux, France
Contact: Adrien Rateau, MD       adrien.rateau@chu-bordeaux.fr   
Contact: Hervé Trillaud, MD, PhD       herve.trillaud@chu-bordeaux.fr   
Sponsors and Collaborators
University Hospital, Bordeaux
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04345003    
Other Study ID Numbers: CHUBX 2018/35
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
HIFU
Fibroid treatment
MR elastography
Perfusion
Diffusion weighted imaging
ARFI
Fibroid stiffness
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases