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Treatment of Breast Fibroadenoma Targeted Tissue With HIFU (HIFU-003)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03044054
Recruitment Status : Recruiting
First Posted : February 6, 2017
Last Update Posted : March 9, 2020
Information provided by (Responsible Party):

Brief Summary:
This study evaluates the efficacy and the safety of the HIFU for the treatment of breast fibroadenoma.

Condition or disease Intervention/treatment Phase
Breast Fibroadenoma Device: ECHOPULSE Not Applicable

Detailed Description:
Echopulse is specially designed, manufactured and CE marked for treating breast fibroadenoma. HIFU is a completely alternative to surgery which utilizes high-energy ultrasound to deliver a large amount of sound energy to a focal point to rapidly induce tissue heating to 85-90°C.This initiates tissue coagulation followed by tissue necrosis ablating the targeted area.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Breast Fibroadenoma Targeted Tissue With High Intensity Focused Ultrasound (HIFU)
Study Start Date : January 2017
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
Experimental: ECHOPULSE
HIFU Under ultrasound guidance

Primary Outcome Measures :
  1. Pain level assessment [ Time Frame: 12 Months ]
    visual analog scale

  2. Anxiety level assessment [ Time Frame: 12 Months ]
    visual analog scale

  3. Volume assessment [ Time Frame: 12 Months ]
    Ultrasound measurement

Secondary Outcome Measures :
  1. The short (6-item) version of the State-Trait Anxiety Inventory (STAI) [ Time Frame: inclusion visit (V0), Day 2/3, Day 7, 6 months, 12 months ]
  2. Palpability of the breast fibroadenoma [ Time Frame: inclusion visit (V0), Day 2/3, Day 7, 6 months, 12 months ]
    Physician clinical examination

  3. Freedom from additional procedures for fibroadenoma of the breast [ Time Frame: Day 2/3, Day 7, 6 months, 12 months ]
    Physician assessment concerning the need of additional procedures

  4. Patient satisfaction [ Time Frame: Month 6 and Months 12 ]
    Self assessment satisfaction questionnaire

  5. Safety endpoints include adverse events (AEs) and serious adverse events (SAEs) occurring at any time during the trial. [ Time Frame: Day 0, Day 2/3, Day 7, 6 months, 12 months ]
    Assessment and capture of adverse events

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  1. Female patients 18 years or older diagnosed with breast fibroadenoma and presenting at least one fibroadenoma.
  2. Diagnosis of fibroadenoma must be based on:

    1. Clinical examination
    2. Ultrasound image alone for patients under 35 years old. For women older than 35 years, a mammogram will be performed in addition to ultrasound. The BI-RADS score of this mammogram must be 2 or 3. BI-RADS score of 4 is eligible if biopsy indicates fibroadenoma with concordance.
    3. Histologic confirmation by core needle biopsy.
  3. Patient is a candidate for the surgery.
  4. The fibroadenoma treatment volume must be at least 5 mm and no more than 26 mm from the skin. This criterion should be evaluated immediately prior treatment, once the breast is immobilized and potentially compressed.
  5. The rib cage should not be in the prefocal ultrasound path or behind the target fibroadenoma (minimum distance from the posterior wall of the fibroadenoma must be at least 10 mm). This criterion shall be evaluated immediately prior to treatment, once breast is immobilized and potentially compressed.
  6. The fibroadenoma is 1 cm or greater at its largest dimension and no less than 7.5 mm in the anterior-posterior dimension (measured by ultrasound). Focal point for HIFU treatment must also be at least 3 mm from any border of the fibroadenoma.
  7. Patient's fibroadenoma size is greater or equal to 0.2 cc and less than 10 cc in volume (measured by ultrasound on the day of the procedure).
  8. Fibroadenoma is palpable.
  9. Pain ≥ 30mm/100mm measured on VAS as a maximum level during the last 30 days
  10. Anxiety ≥ 30mm/100mm measured on VAS as a maximum level during the last 30 days
  11. Patient has signed a written informed consent.

Exclusion Criteria:

  1. Patient is pregnant or nursing.
  2. Presence of calcified fibroadenoma. Calcification will be determined with mammography. In women > 35 years old, the diagnostic mammogram should be evaluated for calcification. In women ≤ 35 years old, a single view mammogram of the affected breast is sufficient for evaluation of calcification. Women ≤ 35 years old will be excluded based on the findings of calcification on a single view mammogram.
  3. Patient with history of breast cancer or history of laser or radiation therapy to the target breast.
  4. Patient with breast implants in the target breast.
  5. Patient with a breast cyst within the fibroadenoma to be treated.
  6. Patient's fibroadenoma not clearly visible on the ultrasound images (in B mode) at the inclusion visit.
  7. 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 identifier (NCT number): NCT03044054

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Contact: Michel NUTA, MD 633404004

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United States, New York
Bellevue Hospital Center Recruiting
New York, New York, United States, 10016
Contact: Jocelyn Acosta         
Principal Investigator: Kathie-Ann Joseph, Prof         
Sub-Investigator: Chloe Chhor, Dr         
Sub-Investigator: Shubhada Dhage, Dr         
New York Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Amanda Alonso         
Principal Investigator: Margaret Chen-Seetoo, Dr         
Montefiore-Einstein Center for Cancer Care Not yet recruiting
New York, New York, United States
Contact: Prena Etchen         
Principal Investigator: REIG Beatriu, MD         
United States, Virginia
University of Virginia Health system Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Katie Rea         
Principal Investigator: David Brenin, Prof         
Sub-Investigator: Carrie Rochmann, Dr         
Sub-Investigator: Jonathon Nguyen, Dr         
Sponsors and Collaborators
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Study Director: Michel NUTA, MD Theraclion
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Responsible Party: Theraclion Identifier: NCT03044054    
Other Study ID Numbers: HIFU/FA/003
First Posted: February 6, 2017    Key Record Dates
Last Update Posted: March 9, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Theraclion:
Additional relevant MeSH terms:
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Neoplasms, Fibroepithelial
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial