Treatment of Breast Fibroadenoma With FastScan HIFU

NCT02488655 | Completed

• 1 other identifier: HIFU/BG/FA/FS/2015
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Fibroadenoma

Outcome Measures

Primary Outcomes (8)

• 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 volume of the fibroadenoma at 6 months

  6 months post treament

• 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

Secondary Outcomes (6)

• 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

• Investigator rated evaluation of the device

  Post treatment Day 0

• Change from Baseline gland vascularization at 3 months

  3 months post treatment

Study Arms (1)

Echopulse

EXPERIMENTAL

Echopulse HIFU

Device: Echopulse

Interventions

Echopulse DEVICE

HIFU Under ultrasound guidance

Also known as: Echopulse HIFU

Echopulse

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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 participating in other trials using drugs or devices.

Sponsors & Collaborators

• Theraclion: lead

Study Sites (1)

University Hospital of Endocrinology USBALE

Sofia, 1431, Bulgaria

Location

MeSH Terms

Conditions

Fibroadenoma

Condition Hierarchy (Ancestors)

Neoplasms, Fibroepithelial; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial

Study Officials

• Roussanka Kovatcheva, Prof.

  roussanka_kov@yahoo.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: July 2, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 19, 2021

Record last verified: 2021-10

Locations

BU (1)