Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test an investigational device called the Echopulse for treatment of breast fibroadenomas in women. Fibroadenomas are benign (noncancerous) breast tumors that are made of glandular and fibrous breast tissue. These lumps can occur alone, in groups, or as a complex of lumps together. Sometimes women feel these in the breast when doing regular self breast exams, or they may be found during a routine mammogram. Some are small (less than an inch in size), and others are quite large (the size of a lemon or larger). This is a study about the Echopulse device, a computer driven system which uses ultrasound to guide a high intensity focused ultrasound beam to a targeted area (the fibroadenoma in the breast). The high intensity focused ultrasound (HIFU) heats the targeted site which causes the cells to die and allows the possibility to treat the fibroadenoma without the need for surgery.

Official Title
-----------------
Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU): A Feasibility Study

Conditions
-----------------
Breast Fibroadenoma

Intervention / Treatment
-----------------
* Device: High Intensity Focused Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of fibroadenoma with histological confirmation of fibroadenoma of the breast Fibroadenoma is palpable Fibroadenoma is 1 cm or greater at its largest dimension and no less than 9 mm in the anterior-posterior dimension Fibroadenoma volume is between 2 cc and 10 cc Patient must give written informed consent (personally signed and dated) before completing any study-related procedure Exclusion Criteria: Patient is pregnant or nursing Patient with breast implants in the target breast Patient with a breast cyst within the fibroadenoma to be treated Patient participating in another clinical trial involving an investigational drug, device or biologic

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIFU treatment<br>The high intensity focused ultrasound (HIFU) will be administered to the targeted site to create heat and cause the cells to die | Device: High Intensity Focused Ultrasound<br>* The Echopulse device is a computer driven system which uses ultrasound to guide a high intensity focused ultrasound beam to a targeted area (the fibroadenoma in the breast).<br>* Other names: Echopulse;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in volume of fibroadenoma | Fibroadenoma volume with be measured by ultrasound. | baseline, 3, 6, and 12 months | 
| Size of fibroadenoma | Fibroadenoma will be assessed by physical examination including measurement of tumor size at clinic visits. | baseline, 3, 6, and 12 months | 
| Patient reported outcomes | Patient-rated pain and patient responses to Satisfaction Questionnaire will be measured at intervals up to 12 months following HIFU treatment session | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | up to 12 months |