Breast Fibroadenoma
Conditions
Brief summary
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 Objectives Primary objective: To evaluate the efficacy of HIFU in the treatment of the breast fibroadenoma using the TH-One device Secondary objective: To evaluate the tolerability of the HIFU using the TH-One device
Interventions
DEVICEEchopulse
HIFU Under ultrasound guidance
Sponsors
Theraclion
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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 procédures 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FA volume changes from baseline | Every year during 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain assessment | Every year during 5 years | Pain free if pain at baseline (pain related to the FA) |
| Cosmetic result | Every year during 5 years | Cosmetic result (as judged by investigator) |
| Gland vascularisation | Every year during 5 years | Gland vascularisation (compared to baseline) power Doppler at day 7, month 6 and 12, year 2, 3, 4 and 5 after the HIFU session |
| Histological outcome | Every year during 5 years | Histological outcome through core needle biopsy after 12 month |
| Palpability | Every year during 5 years | Lack of palpable lesion |
| Breast immobilization | Every year during 5 years | Quality and ease of use of breast immobilization |
| Duration of the treatment session | Every year during 5 years | Duration of the treatment session (min) |
| Ease of implementation of treatment | Every year during 5 years | Ease of implementation of treatment |
| Energy settings | Every year during 5 years | Energy setting to obtain reduction in volume or total regression of the FA at 12 months, 2, 3, 4 and 5 years follow-up |
Countries
Germany
Outcome results
None listed