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.

Study Overview

• Status: Completed
• Conditions: Breast Fibroadenoma
• Intervention / Treatment: Device: High Intensity Focused Ultrasound

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

Contacts and Locations

Study Locations

• Germany
  • Tübingen, Germany, 72076
    • Department for Women's Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: University Women's Hospital Tübingen
• Collaborators: Theraclion

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: July 1, 2015
• First Submitted That Met QC Criteria: January 11, 2017
• First Posted (Estimate): January 16, 2017

Study Record Updates

• Last Update Posted (Estimate): January 20, 2017
• Last Update Submitted That Met QC Criteria: January 19, 2017
• Last Verified: June 1, 2015

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 1.0