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

Primary Purpose

Breast Fibroadenoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Intensity Focused Ultrasound
Sponsored by
David R. Brenin, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Fibroadenoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Virginia Health System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HIFU treatment

Arm Description

The high intensity focused ultrasound (HIFU) will be administered to the targeted site to create heat and cause the cells to die

Outcomes

Primary Outcome Measures

Change in volume of fibroadenoma
Fibroadenoma volume with be measured by ultrasound.
Size of fibroadenoma
Fibroadenoma will be assessed by physical examination including measurement of tumor size at clinic visits.
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

Secondary Outcome Measures

Incidence of adverse events

Full Information

First Posted
February 25, 2014
Last Updated
May 1, 2018
Sponsor
David R. Brenin, MD
Collaborators
Theraclion SAS, Paris, France
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1. Study Identification

Unique Protocol Identification Number
NCT02078011
Brief Title
Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound
Acronym
HIFU-FA-001
Official Title
Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU): A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
August 29, 2016 (Actual)
Study Completion Date
October 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David R. Brenin, MD
Collaborators
Theraclion SAS, Paris, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Fibroadenoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIFU treatment
Arm Type
Experimental
Arm Description
The high intensity focused ultrasound (HIFU) will be administered to the targeted site to create heat and cause the cells to die
Intervention Type
Device
Intervention Name(s)
High Intensity Focused Ultrasound
Other Intervention Name(s)
Echopulse
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in volume of fibroadenoma
Description
Fibroadenoma volume with be measured by ultrasound.
Time Frame
baseline, 3, 6, and 12 months
Title
Size of fibroadenoma
Description
Fibroadenoma will be assessed by physical examination including measurement of tumor size at clinic visits.
Time Frame
baseline, 3, 6, and 12 months
Title
Patient reported outcomes
Description
Patient-rated pain and patient responses to Satisfaction Questionnaire will be measured at intervals up to 12 months following HIFU treatment session
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Incidence of adverse events
Time Frame
up to 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Brenin, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound

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