Treatment of Breast Fibroadenoma With FastScan HIFU

Study Overview
=================
Brief Summary
-----------------
This study evaluates the efficacy of the HIFU for the treatment of breast fibroadenoma with the FastScan version using assessment of patient experience and adverse event reporting.

Detailed Description
-----------------
Echopulse is specially designed, manufactured and CE marked for treating breast fibroadenoma. HIFU is a completely alternative to surgery which utilizes high-energy ultrasound to deliver a large amount of sound energy to a focal point to rapidly induce tissue heating to 85-90°C.This initiates tissue coagulation followed by tissue necrosis ablating the targeted area. In a previous european feasibility study performed at 4 sites (France and Bulgaria), 51 fibroadenomas in 42 patients were treated. The HIFU treatment was well tolerated and showed efficacy (mean volume reduction of 72.5% +/-16.7 at 12 months follow-up.

Official Title
-----------------
Treatment of Breast Fibroadenoma With FastScan High Intensity Focused Ultrasound (HIFU)

Conditions
-----------------
Breast Fibroadenoma

Intervention / Treatment
-----------------
* Device: Echopulse


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients 18 years or older with one diagnosed breast fibroadenoma. Diagnosis of fibroadenoma must be based on : clinical examination, ultrasound image alone for patients under 35 years old. For women older than 35 years, a mammogram will be performed in addition to ultrasound. The BI-RADS (Breast Imaging, Reporting and Data System) score of this mammogram must be less than 3. histologic confirmation after core needle biopsy by two independent readers (biopsy must be performed at least two weeks before therapy unless a microbiopsy has been already done less than 3 months before inclusion visit and histopathology slices are available). The requirements for the distance from the skin and the following regions of the fibroadenoma are: ≤ 23 mm from the posterior border of the fibroadenoma ≥ 5 mm from the anterior border of the fibroadenoma ≥ 11mm from the focal point of the HIFU treatment. These criteria shall be evaluated immediately prior to treatment once breast is immobilized and potentially compressed The rib cage should not be in the prefocal ultrasound path or behind the target fibroadenoma (minimum distance behind the focal point= 10 mm). This criterion shall only be reached in treatment conditions, once breast is immobilized and potentially compressed. Patient's fibroadenoma is 1 cm or greater at its largest dimension Fibroadenoma is palpable Patient has signed a written informed consent. Exclusion Criteria: Patient who is pregnant or lactating. Patient with a BI-RADS score > 2 at the mammogram, or presence of microcalcifications within the lesion. Patient with history of breast cancer or history Patient with history of laser or radiation therapy to the target breast Patient with breast implants in the target breast Patient with a breast cyst Patient's fibroadenoma not clearly visible on the ultrasound images (in B mode) at the inclusion visit Patient participating in other trials using drugs or devices.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Echopulse<br>Echopulse HIFU | Device: Echopulse<br>* HIFU Under ultrasound guidance<br>* Other names: Echopulse HIFU;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | 1 day post treatment | 
| Number of participants with adverse events |  | 3 days post treatment | 
| Number of participants with adverse events |  | 7 days post treatment | 
| Change from Baseline volume of the fibroadenoma at 6 months |  | 6 months post treament | 
| Change from Baseline Patient pain intensity score (100mm visual analog scale) at 1 day |  | 1 day post treatment | 
| Change from Baseline Patient pain intensity score (100mm visual analog scale) at 3 days |  | 3 days post treatment | 
| Change from Baseline Patient pain intensity score (100mm visual analog scale) at 7 days |  | 7 days post treatment | 
| Patient satisfaction questionnaire |  | 6 months post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with absence of palpable lesion |  | 3 months post treatment | 
| Number of participants with absence of palpable lesion |  | 6 months post treatment | 
| Patient Cosmetic evaluation as measured by questionnaire |  | 6 months post treatment | 
| Investigator rated evaluation of the device |  | Post treatment Day 0 | 
| Change from Baseline gland vascularization at 3 months |  | 3 months post treatment | 
| Change from Baseline gland vascularization at 6 months |  | 6 months post treatment |