Treatment of Breast Fibroadenoma With FastScan HIFU

Breast Fibroadenoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02488655
• Other study ID #: HIFU/BG/FA/FS/2015
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: December 2018

Study information

• Verified date: October 2021
• Source: Theraclion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Fibroadenoma
• Fibroadenoma

Intervention

Device:
• Echopulse
HIFU Under ultrasound guidance

Locations

Country	Name	City	State
Bulgaria	University Hospital of Endocrinology USBALE	Sofia

Sponsors (1)

Lead Sponsor	Collaborator
Theraclion

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events		1 day post treatment
Primary	Number of participants with adverse events		3 days post treatment
Primary	Number of participants with adverse events		7 days post treatment
Primary	Change from Baseline volume of the fibroadenoma at 6 months		6 months post treament
Primary	Change from Baseline Patient pain intensity score (100mm visual analog scale) at 1 day		1 day post treatment
Primary	Change from Baseline Patient pain intensity score (100mm visual analog scale) at 3 days		3 days post treatment
Primary	Change from Baseline Patient pain intensity score (100mm visual analog scale) at 7 days		7 days post treatment
Primary	Patient satisfaction questionnaire		6 months post treatment
Secondary	Number of participants with absence of palpable lesion		3 months post treatment
Secondary	Number of participants with absence of palpable lesion		6 months post treatment
Secondary	Patient Cosmetic evaluation as measured by questionnaire		6 months post treatment
Secondary	Investigator rated evaluation of the device		Post treatment Day 0
Secondary	Change from Baseline gland vascularization at 3 months		3 months post treatment
Secondary	Change from Baseline gland vascularization at 6 months		6 months post treatment