Skip to main content
OpenTrials
Completed

NCT Number: NCT02078011

Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Fibroadenoma Fibroadenoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibroepithelial Neoplasms, Fibrous Tissue Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Intensity Focused Ultrasound

Device

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

Primary outcomes

  1. Change in volume of fibroadenoma

    Time frame: baseline, 3, 6, and 12 months

    Fibroadenoma volume with be measured by ultrasound.

  2. 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.

  3. 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

Secondary outcomes

  1. Incidence of adverse events

    Time frame: up to 12 months

Sponsors and collaborators

Lead sponsor

David R. Brenin, MD

Other

Collaborators

  • Theraclion SAS, Paris, France

Registry information

Official study title

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

Acronym: HIFU-FA-001

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Mar 4, 2014
Registry last updated
May 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.