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

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

Study Overview

• Status: Completed
• Conditions: Breast Fibroadenoma
• Intervention / Treatment: Device: Echopulse

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Tubingen, Germany
    • Tübingen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Echopulse; Echopulse HIFU	Device: Echopulse; HIFU Under ultrasound guidance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
FA volume changes from baseline	Every year during 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Palpability	Lack of palpable lesion	Every year during 5 years
Pain assessment	Pain free if pain at baseline (pain related to the FA)	Every year during 5 years
Cosmetic result	Cosmetic result (as judged by investigator)	Every year during 5 years
Gland vascularisation	Gland vascularisation (compared to baseline) power Doppler at day 7, month 6 and 12, year 2, 3, 4 and 5 after the HIFU session	Every year during 5 years
Histological outcome	Histological outcome through core needle biopsy after 12 month	Every year during 5 years
Energy settings	Energy setting to obtain reduction in volume or total regression of the FA at 12 months, 2, 3, 4 and 5 years follow-up	Every year during 5 years
Breast immobilization	Quality and ease of use of breast immobilization	Every year during 5 years
Duration of the treatment session	Duration of the treatment session (min)	Every year during 5 years
Ease of implementation of treatment	Ease of implementation of treatment	Every year during 5 years

Collaborators and Investigators

• Sponsor: Theraclion

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (ACTUAL): January 1, 2017
• Study Completion (ACTUAL): January 1, 2017

Study Registration Dates

• First Submitted: December 10, 2013
• First Submitted That Met QC Criteria: December 12, 2013
• First Posted (ESTIMATE): December 13, 2013

Study Record Updates

• Last Update Posted (ACTUAL): May 30, 2018
• Last Update Submitted That Met QC Criteria: May 25, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Connective Tissue; Neoplasms, Fibrous Tissue; Neoplasms, Fibroepithelial; Fibroadenoma
• Other Study ID Numbers: HIFU / TU / FA