Clinical trial NCT02011919: 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: Theraclion
Sponsor class: INDUSTRY
First posted: 2013-12-13
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

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


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 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.

Primary outcomes:
measure: FA volume changes from baseline
timeFrame: Every year during 5 years
Secondary outcomes:
measure: Palpability
timeFrame: Every year during 5 years
measure: Pain assessment
timeFrame: Every year during 5 years
measure: Cosmetic result
timeFrame: Every year during 5 years
measure: Gland vascularisation
timeFrame: Every year during 5 years
measure: Histological outcome
timeFrame: Every year during 5 years
measure: Energy settings
timeFrame: Every year during 5 years
measure: Breast immobilization
timeFrame: Every year during 5 years
measure: Duration of the treatment session
timeFrame: Every year during 5 years
measure: Ease of implementation of treatment
timeFrame: Every year during 5 years
Other outcomes:
Locations:
city: Tubingen
country: Germany
facility: Tubingen University Hospital
Study officials:
References:
citation: Hahn M, Fugunt R, Schoenfisch B, Oberlechner E, Gruber IV, Hoopmann U, Roehm C, Helms G, Taran FA, Hartkopf AD, Warzecha H, Wiesinger B, Brucker SY, Boeer B. High intensity focused ultrasound (HIFU) for the treatment of symptomatic breast fibroadenoma. Int J Hyperthermia. 2018;35(1):463-470. doi: 10.1080/02656736.2018.1508757. Epub 2018 Sep 11.