Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)

Study Overview
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Brief Summary
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This is a monocenter, open-label, uncontrolled study in accordance with §23b MPG to evaluate the efficacy of the HIFU-treatment of fibroadenoma using the TH-One device.

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

Conditions
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Breast Fibroadenoma

Intervention / Treatment
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* Device: High Intensity Focused Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients 18 years or older with at least one diagnosed breast fibroadenoma. Diagnosis of fibroadenoma must be based on: clinical examination, women ≤ 40 years of age: ultrasound image alone; women > 40 years of age: ultrasound image and mammogram, histological confirmation of fibroadenoma of the breast. Patient's fibroadenoma size as determined by ultrasound imaging: the longest diameter is limited to 25 mm. Women of childbearing potential must have a negative urine pregnancy test within 72 hours prior to HIFU treatment. Patient must be able to understand the nature and the extent of the study and the procedures required and be willing and able to complete the screening and study procedures. Patient must give written informed consent (personally signed and dated) before completing any study-related procedure. Exclusion Criteria: Patient who is pregnant or breast-feeding. Patient with history of ipsilateral breast cancer within 5 years prior to study inclusion or radio therapy to the target breast within 5 years prior to study inclusion. Patient with implant on the treated breast. Patient with target fibroadenoma pre-treated by cryoablation or interstitial laser therapy within 12 month before recruiting for HIFU. Patient's fibroadenoma not clearly visible on the ultrasound images (in B mode) at the inclusion visit. Patient participating in other studies using drugs or medical devices within 3 months prior to study inclusion or during study participation including the follow-up period.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with high-intensity focused ultrasound<br> | Device: High Intensity Focused Ultrasound<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy is assessed by a reduction in volume of the fibroadenoma at baseline, 6 months and at 12 months after the HIFU on the ultrasonography. | A reduction in volume of > 65% compared to baseline, or a total regression of the fibroadenoma will be taken as effective treatment. The results will be analyzed descriptively | Baseline, 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy setting to obtain reduction in volume or total regression of the fibroadenoma at 12 months follow-up |  | 1 year | 
| Lack of palpable lesion |  | 2 years | 
| Pain free if pain at baseline (pain related to the fibroadenoma) |  | 1 year | 
| Gland vascularisation (compared to baseline) power Doppler at day 7, month 6 and 12 after the HIFU session |  | Day 7, month 6, month 12 | 
| Pain during the HIFU session using a Visual Analog Pain Scale |  | 0 month | 
| Histological outcome through core needle biopsy after 12 month |  | 1 year | 
| Quality and ease of use of breast immobilization |  | 1 year |