Treatment of Breast Fibroadenoma With FastScan HIFU

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

This study evaluates the efficacy of the HIFU for the treatment of breast fibroadenoma with the FastScan version using assessment of patient experience and adverse event reporting.

Study Overview

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

Detailed Description

Echopulse is specially designed, manufactured and CE marked for treating breast fibroadenoma. HIFU is a completely alternative to surgery which utilizes high-energy ultrasound to deliver a large amount of sound energy to a focal point to rapidly induce tissue heating to 85-90°C.This initiates tissue coagulation followed by tissue necrosis ablating the targeted area.

In a previous european feasibility study performed at 4 sites (France and Bulgaria), 51 fibroadenomas in 42 patients were treated. The HIFU treatment was well tolerated and showed efficacy (mean volume reduction of 72.5% +/-16.7 at 12 months follow-up.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria, 1431
    • University Hospital of Endocrinology USBALE

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 one diagnosed breast fibroadenoma.

• Diagnosis of fibroadenoma must be based on :

  • clinical examination,
  • ultrasound image alone for patients under 35 years old. For women older than 35 years, a mammogram will be performed in addition to ultrasound. The BI-RADS (Breast Imaging, Reporting and Data System) score of this mammogram must be less than 3.
  • histologic confirmation after core needle biopsy by two independent readers (biopsy must be performed at least two weeks before therapy unless a microbiopsy has been already done less than 3 months before inclusion visit and histopathology slices are available).

• The requirements for the distance from the skin and the following regions of the fibroadenoma are:

  • ≤ 23 mm from the posterior border of the fibroadenoma
  • ≥ 5 mm from the anterior border of the fibroadenoma
  • ≥ 11mm from the focal point of the HIFU treatment. These criteria shall be evaluated immediately prior to treatment once breast is immobilized and potentially compressed
• The rib cage should not be in the prefocal ultrasound path or behind the target fibroadenoma (minimum distance behind the focal point= 10 mm). This criterion shall only be reached in treatment conditions, once breast is immobilized and potentially compressed.
• Patient's fibroadenoma is 1 cm or greater at its largest dimension
• Fibroadenoma is palpable
• Patient has signed a written informed consent.

Exclusion Criteria:

• Patient who is pregnant or lactating.
• Patient with a BI-RADS score > 2 at the mammogram, or presence of microcalcifications within the lesion.
• Patient with history of breast cancer or history
• Patient with history of laser or radiation therapy to the target breast
• Patient with breast implants in the target breast
• Patient with a breast cyst
• Patient's fibroadenoma not clearly visible on the ultrasound images (in B mode) at the inclusion visit
• Patient participating in other trials using drugs or devices.

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: Echopulse; Echopulse HIFU	Device: Echopulse; HIFU Under ultrasound guidance; Other Names: Echopulse HIFU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events	1 day post treatment
Number of participants with adverse events	3 days post treatment
Number of participants with adverse events	7 days post treatment
Change from Baseline Patient pain intensity score (100mm visual analog scale) at 1 day	1 day post treatment
Change from Baseline Patient pain intensity score (100mm visual analog scale) at 3 days	3 days post treatment
Change from Baseline Patient pain intensity score (100mm visual analog scale) at 7 days	7 days post treatment
Patient satisfaction questionnaire	6 months post treatment
Change from Baseline volume of the fibroadenoma at 6 months	6 months post treament

Secondary Outcome Measures

Outcome Measure	Time Frame
Investigator rated evaluation of the device	Post treatment Day 0
Number of participants with absence of palpable lesion	3 months post treatment
Number of participants with absence of palpable lesion	6 months post treatment
Patient Cosmetic evaluation as measured by questionnaire	6 months post treatment
Change from Baseline gland vascularization at 3 months	3 months post treatment
Change from Baseline gland vascularization at 6 months	6 months post treatment

Collaborators and Investigators

• Sponsor: Theraclion
• Investigators: Principal Investigator: Roussanka Kovatcheva, Prof., roussanka_kov@yahoo.com

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: June 24, 2015
• First Submitted That Met QC Criteria: July 1, 2015
• First Posted (Estimate): July 2, 2015

Study Record Updates

• Last Update Posted (Actual): October 19, 2021
• Last Update Submitted That Met QC Criteria: October 11, 2021
• Last Verified: October 1, 2021

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/BG/FA/FS/2015