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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04345003
Other study ID # CHUBX 2018/35
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 18, 2020
Est. completion date August 31, 2023

Study information

Verified date December 2023
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date August 31, 2023
Est. primary completion date February 21, 2023
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. - 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
France CHU Bordeaux 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 Composite criteria Composite criteria measured from:
myoma stiffness (measured by Resoundant system) and
ablathermy efficiency.
Baseline
Secondary leiomyoma stiffness measured by Resoundant system leiomyoma stiffness measured by Resoundant system Baseline
Secondary leiomyoma stiffness measured by ARFI-US leiomyoma stiffness measured by ARFI-US Baseline
Secondary clinical efficiency Defined as a decrease of 10pts on UFS-Qol score month 6
Secondary inter-observer reproducibility inter-observer reproducibility of leiomyoma stiffness measurements by Resoundant system Baseline
Secondary leiomyoma perfusion leiomyoma perfusion (diffusion) Month 6
Secondary 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.
Month 6
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