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: NCT02011919
• Other study ID #: HIFU / TU / FA
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: January 2017

Study information

• Verified date: May 2018
• Source: Theraclion
• 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• 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 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.

Related Conditions & MeSH terms

• Breast Fibroadenoma
• Fibroadenoma

Intervention

Device:
• Echopulse
HIFU Under ultrasound guidance

Locations

Country	Name	City	State
Germany	Tubingen University Hospital	Tubingen

Sponsors (1)

Lead Sponsor	Collaborator
Theraclion

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FA volume changes from baseline		Every year during 5 years
Secondary	Palpability	Lack of palpable lesion	Every year during 5 years
Secondary	Pain assessment	Pain free if pain at baseline (pain related to the FA)	Every year during 5 years
Secondary	Cosmetic result	Cosmetic result (as judged by investigator)	Every year during 5 years
Secondary	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
Secondary	Histological outcome	Histological outcome through core needle biopsy after 12 month	Every year during 5 years
Secondary	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
Secondary	Breast immobilization	Quality and ease of use of breast immobilization	Every year during 5 years
Secondary	Duration of the treatment session	Duration of the treatment session (min)	Every year during 5 years
Secondary	Ease of implementation of treatment	Ease of implementation of treatment	Every year during 5 years