Clinical Trial: Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary:
Sponsor: David R. Brenin, MD

Current Primary Outcome:

• Change in volume of fibroadenoma [ Time Frame: baseline, 3, 6, and 12 months ]
  Fibroadenoma volume with be measured by ultrasound.
• Size of fibroadenoma [ Time Frame: baseline, 3, 6, and 12 months ]
  Fibroadenoma will be assessed by physical examination including measurement of tumor size at clinic visits.
• Patient reported outcomes [ Time Frame: 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

Original Primary Outcome: Same as current

Current Secondary Outcome: Incidence of adverse events [ Time Frame: up to 12 months ]

Original Secondary Outcome: Same as current

Information By: University of Virginia

Dates:
Date Received: February 25, 2014
Date Started: April 2014
Date Completion: October 2017
Last Updated: November 14, 2016
Last Verified: November 2016