Breast Fibroadenoma
Conditions
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.
Interventions
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).
Sponsors
Theraclion SAS, Paris, France
David R. Brenin, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in volume of fibroadenoma | baseline, 3, 6, and 12 months | Fibroadenoma volume with be measured by ultrasound. |
| Size of fibroadenoma | baseline, 3, 6, and 12 months | Fibroadenoma will be assessed by physical examination including measurement of tumor size at clinic visits. |
| Patient reported outcomes | up to 12 months | Patient-rated pain and patient responses to Satisfaction Questionnaire will be measured at intervals up to 12 months following HIFU treatment session |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | up to 12 months |
Countries
United States
Outcome results
None listed