Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound

NCT02078011 | Completed DMC

• 1 other identifier: 17277
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Fibroadenoma

Outcome Measures

Primary Outcomes (3)

• Change in volume of fibroadenoma

  Fibroadenoma volume with be measured by ultrasound.

  baseline, 3, 6, and 12 months

• Size of fibroadenoma

  Fibroadenoma will be assessed by physical examination including measurement of tumor size at clinic visits.

  baseline, 3, 6, and 12 months

• 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 Outcomes (1)

• Incidence of adverse events

  up to 12 months

Study Arms (1)

HIFU treatment

EXPERIMENTAL

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

Interventions

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).

Also known as: Echopulse

HIFU treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• David R. Brenin, MD: lead
• Theraclion SAS, Paris, France: collaborator

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Fibroadenoma

Condition Hierarchy (Ancestors)

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

Study Officials

• David Brenin, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Department of Surgery

Study Record Dates

• First Submitted: February 25, 2014
• First Posted: March 4, 2014
• Study Start: April 1, 2014
• Primary Completion: August 29, 2016
• Study Completion: October 1, 2017
• Last Updated: May 7, 2018

Record last verified: 2018-05

Locations

US (1)