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Treatment of Breast Fibroadenoma With FastScan HIFU

Primary Purpose

Breast Fibroadenoma

Status

Completed

Phase

Not Applicable

Locations

Bulgaria

Study Type

Interventional

Intervention

Echopulse

About this trial

This is an interventional treatment trial for Breast Fibroadenoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

University Hospital of Endocrinology USBALE

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Echopulse

Arm Description

Echopulse HIFU

Outcomes

Primary Outcome Measures

Number of participants with adverse events

Change from Baseline volume of the fibroadenoma at 6 months

Change from Baseline Patient pain intensity score (100mm visual analog scale) at 1 day

Change from Baseline Patient pain intensity score (100mm visual analog scale) at 3 days

Change from Baseline Patient pain intensity score (100mm visual analog scale) at 7 days

Patient satisfaction questionnaire

Secondary Outcome Measures

Number of participants with absence of palpable lesion

Patient Cosmetic evaluation as measured by questionnaire

Investigator rated evaluation of the device

Change from Baseline gland vascularization at 3 months

Change from Baseline gland vascularization at 6 months

Full Information

NCT ID

NCT02488655

First Posted

June 24, 2015

Last Updated

October 11, 2021

Sponsor

Theraclion

1. Study Identification

Unique Protocol Identification Number

NCT02488655

Brief Title

Treatment of Breast Fibroadenoma With FastScan HIFU

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

June 2015 (undefined)

Primary Completion Date

December 2018 (Actual)

Study Completion Date

December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Theraclion

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Fibroadenoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Echopulse

Arm Type

Experimental

Arm Description

Echopulse HIFU

Intervention Type

Device

Intervention Name(s)

Echopulse

Other Intervention Name(s)

Echopulse HIFU

Intervention Description

HIFU Under ultrasound guidance

Primary Outcome Measure Information:

Title

Number of participants with adverse events

Time Frame

1 day post treatment

Title

Number of participants with adverse events

Time Frame

3 days post treatment

Title

Number of participants with adverse events

Time Frame

7 days post treatment

Title

Change from Baseline volume of the fibroadenoma at 6 months

Time Frame

6 months post treament

Title

Change from Baseline Patient pain intensity score (100mm visual analog scale) at 1 day

Time Frame

1 day post treatment

Title

Change from Baseline Patient pain intensity score (100mm visual analog scale) at 3 days

Time Frame

3 days post treatment

Title

Change from Baseline Patient pain intensity score (100mm visual analog scale) at 7 days

Time Frame

7 days post treatment

Title

Patient satisfaction questionnaire

Time Frame

6 months post treatment

Secondary Outcome Measure Information:

Title

Number of participants with absence of palpable lesion

Time Frame

3 months post treatment

Title

Number of participants with absence of palpable lesion

Time Frame

6 months post treatment

Title

Patient Cosmetic evaluation as measured by questionnaire

Time Frame

6 months post treatment

Title

Investigator rated evaluation of the device

Time Frame

Post treatment Day 0

Title

Change from Baseline gland vascularization at 3 months

Time Frame

3 months post treatment

Title

Change from Baseline gland vascularization at 6 months

Time Frame

6 months post treatment

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roussanka Kovatcheva, Prof.

Organizational Affiliation

roussanka_kov@yahoo.com

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital of Endocrinology USBALE

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

12. IPD Sharing Statement

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Treatment of Breast Fibroadenoma With FastScan HIFU

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