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

NCT ID: NCT04345003

Last Updated: 2023-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-18

Study Completion Date

2023-08-31

Brief Summary

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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

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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.

Conditions

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Uterine Fibroid

Keywords

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HIFU Fibroid treatment MR elastography Perfusion Diffusion weighted imaging ARFI Fibroid stiffness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Myoma elastography

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Bordeaux

Bordeaux, , France

Site Status

Countries

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France

Other Identifiers

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CHUBX 2018/35

Identifier Type: -

Identifier Source: org_study_id