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

Not Applicable

Completed

• Conditions: Breast Fibroadenoma
• Interventions: Device: Echopulse

• Registration Number: NCT02011919
• Lead Sponsor: Theraclion

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-10
• Study First Submitted QC: 2013-12-12
• Study First Posted: 2013-12-13
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-25
• Last Update Posted: 2018-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Echopulse	Echopulse	Echopulse HIFU

Primary Outcome Measures

Name	Time	Method
FA volume changes from baseline	Every year during 5 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tubingen University Hospital; 🇩🇪 Tubingen, Germany