Clinical trial NCT03022695: Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)
Official title: Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Fibroadenoma
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: Theraclion
First posted: 2017-01-16
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Baseline, 6 months, 12 months
Secondary outcomes:
measure: Energy setting to obtain reduction in volume or total regression of the fibroadenoma at 12 months follow-up
timeFrame: 1 year
measure: Lack of palpable lesion
timeFrame: 2 years
measure: Pain free if pain at baseline (pain related to the fibroadenoma)
timeFrame: 1 year
measure: Gland vascularisation (compared to baseline) power Doppler at day 7, month 6 and 12 after the HIFU session
timeFrame: Day 7, month 6, month 12
measure: Pain during the HIFU session using a Visual Analog Pain Scale
timeFrame: 0 month
measure: Histological outcome through core needle biopsy after 12 month
timeFrame: 1 year
measure: Quality and ease of use of breast immobilization
timeFrame: 1 year
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Department for Women's Health
Study officials:
References: