Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU-FA-001)

May 1, 2018 updated by: David R. Brenin, MD

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HIFU treatment
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
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).
Other Names:
  • Echopulse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in volume of fibroadenoma
Time Frame: baseline, 3, 6, and 12 months
Fibroadenoma volume with be measured by ultrasound.
baseline, 3, 6, and 12 months
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.
baseline, 3, 6, and 12 months
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
up to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events
Time Frame: up to 12 months
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

David R. Brenin, MD

Collaborators

Theraclion SAS, Paris, France

Investigators

  • Principal Investigator: David Brenin, MD, University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

August 29, 2016

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

February 25, 2014

First Submitted That Met QC Criteria

February 28, 2014

First Posted (Estimate)

March 4, 2014

Study Record Updates

Last Update Posted (Actual)

May 7, 2018

Last Update Submitted That Met QC Criteria

May 1, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17277

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Fibroadenoma

Clinical Trials on High Intensity Focused Ultrasound

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe