Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound

Breast Fibroadenoma Clinical Trial

— HIFU-FA-001  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02078011
• Other study ID #: 17277
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: October 1, 2017

Study information

• Verified date: May 2018
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 1, 2017
• Est. primary completion date: August 29, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Fibroadenoma
• Fibroadenoma

Intervention

Device:
• High Intensity Focused Ultrasound
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).

Locations

Country	Name	City	State
United States	University of Virginia Health System	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
David R. Brenin, MD	Theraclion SAS, Paris, France

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in volume of fibroadenoma	Fibroadenoma volume with be measured by ultrasound.	baseline, 3, 6, and 12 months
Primary	Size of fibroadenoma	Fibroadenoma will be assessed by physical examination including measurement of tumor size at clinic visits.	baseline, 3, 6, and 12 months
Primary	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	Incidence of adverse events		up to 12 months