Treatment of Breast Fibroadenoma With FastScan HIFU

NCT ID: NCT02488655

Last Updated: 2021-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2018-12-31

Brief 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.

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.

Conditions

Breast Fibroadenoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Echopulse

Echopulse HIFU

Group Type: EXPERIMENTAL

Echopulse

Intervention Type: DEVICE

HIFU Under ultrasound guidance

Interventions

Echopulse

HIFU Under ultrasound guidance

Intervention Type: DEVICE

Other Intervention Names

Echopulse HIFU

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Theraclion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roussanka Kovatcheva, Prof.

Role: PRINCIPAL_INVESTIGATOR

roussanka_kov@yahoo.com

Locations

University Hospital of Endocrinology USBALE

Sofia, , Bulgaria

Countries

Bulgaria

Other Identifiers

HIFU/BG/FA/FS/2015

Identifier Type: -

Identifier Source: org_study_id