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

Breast Fibroadenoma Clinical Trial

— HIFU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03022695
• Other study ID #: HIFU 1.0
• Status: Completed
• Phase: N/A
• First received: July 1, 2015
• Last updated: January 19, 2017
• Start date: October 2013
• Est. completion date: December 2015

Study information

• Verified date: June 2015
• Source: University Women's Hospital Tübingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Fibroadenoma
• Fibroadenoma

Intervention

Device:
• High Intensity Focused Ultrasound

Locations

Country	Name	City	State
Germany	Department for Women's Health	Tübingen

Sponsors (2)

Lead Sponsor	Collaborator
University Women's Hospital Tübingen	Theraclion

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Energy setting to obtain reduction in volume or total regression of the fibroadenoma at 12 months follow-up		1 year
Secondary	Lack of palpable lesion		2 years
Secondary	Pain free if pain at baseline (pain related to the fibroadenoma)		1 year
Secondary	Gland vascularisation (compared to baseline) power Doppler at day 7, month 6 and 12 after the HIFU session		Day 7, month 6, month 12
Secondary	Pain during the HIFU session using a Visual Analog Pain Scale		0 month
Secondary	Histological outcome through core needle biopsy after 12 month		1 year
Secondary	Quality and ease of use of breast immobilization		1 year