Clinical trial NCT02488655: Treatment of Breast Fibroadenoma With FastScan HIFU
Official title: Treatment of Breast Fibroadenoma With FastScan High Intensity Focused Ultrasound (HIFU)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Fibroadenoma
Lead sponsor: Theraclion
Sponsor class: INDUSTRY
First posted: 2015-07-02
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: 1 day post treatment
measure: Number of participants with adverse events
timeFrame: 3 days post treatment
measure: Number of participants with adverse events
timeFrame: 7 days post treatment
measure: Change from Baseline volume of the fibroadenoma at 6 months
timeFrame: 6 months post treament
measure: Change from Baseline Patient pain intensity score (100mm visual analog scale) at 1 day
timeFrame: 1 day post treatment
measure: Change from Baseline Patient pain intensity score (100mm visual analog scale) at 3 days
timeFrame: 3 days post treatment
measure: Change from Baseline Patient pain intensity score (100mm visual analog scale) at 7 days
timeFrame: 7 days post treatment
measure: Patient satisfaction questionnaire
timeFrame: 6 months post treatment
Secondary outcomes:
measure: Number of participants with absence of palpable lesion
timeFrame: 3 months post treatment
measure: Number of participants with absence of palpable lesion
timeFrame: 6 months post treatment
measure: Patient Cosmetic evaluation as measured by questionnaire
timeFrame: 6 months post treatment
measure: Investigator rated evaluation of the device
timeFrame: Post treatment Day 0
measure: Change from Baseline gland vascularization at 3 months
timeFrame: 3 months post treatment
measure: Change from Baseline gland vascularization at 6 months
timeFrame: 6 months post treatment
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: University Hospital of Endocrinology USBALE
Study officials:
affiliation: roussanka_kov@yahoo.com
name: Roussanka Kovatcheva, Prof.
role: PRINCIPAL_INVESTIGATOR
References: