Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound

Not Applicable

Completed

• Conditions: Breast Fibroadenoma
• Interventions: Device: High Intensity Focused Ultrasound

• Registration Number: NCT02078011
• Lead Sponsor: David R. Brenin, MD

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-25
• Study First Submitted QC: 2014-02-28
• Study First Posted: 2014-03-04
• Study Start: 2014-04
• Primary Completion: 2016-08-29
• Study Completion: 2017-10-01
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-01
• Last Update Posted: 2018-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HIFU treatment	High Intensity Focused Ultrasound	The high intensity focused ultrasound (HIFU) will be administered to the targeted site to create heat and cause the cells to die

Primary Outcome Measures

Name	Time	Method
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
Change in volume of fibroadenoma	baseline, 3, 6, and 12 months	Fibroadenoma volume with be measured by ultrasound.

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events	up to 12 months

Trial Locations

Locations (1)

University of Virginia Health System; 🇺🇸 Charlottesville, Virginia, United States