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

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ClinicalTrials.gov Identifier: NCT02078011
Recruitment Status : Completed
First Posted : March 4, 2014
Last Update Posted : May 7, 2018
Sponsor:
Collaborator:
Theraclion SAS, Paris, France
Information provided by (Responsible Party):
David R. Brenin, MD, University of Virginia

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.


Condition or disease Intervention/treatment Phase
Breast Fibroadenoma Device: High Intensity Focused Ultrasound Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU): A Feasibility Study
Study Start Date : April 2014
Actual Primary Completion Date : August 29, 2016
Actual Study Completion Date : October 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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 Name: Echopulse




Primary Outcome Measures :
  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 Outcome Measures :
  1. Incidence of adverse events [ Time Frame: up to 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02078011


Locations
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United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
David R. Brenin, MD
Theraclion SAS, Paris, France
Investigators
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Principal Investigator: David Brenin, MD University of Virginia

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Responsible Party: David R. Brenin, MD, Associate Professor, Department of Surgery, University of Virginia
ClinicalTrials.gov Identifier: NCT02078011     History of Changes
Other Study ID Numbers: 17277
First Posted: March 4, 2014    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Fibroadenoma
Neoplasms, Fibroepithelial
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial