Treatment of Breast Fibroadenoma With FastScan HIFU
Primary Purpose
Breast Fibroadenoma
Status
Completed
Phase
Not Applicable
Locations
Bulgaria
Study Type
Interventional
Intervention
Echopulse
Sponsored by
About this trial
This is an interventional treatment trial for Breast Fibroadenoma
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.
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
Number of participants with adverse events
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
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
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
No
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
No
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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