Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03742401
Recruitment Status : Terminated (Changes to the HIFU-SURG-FA study protocol, a number of centers have decided not to continue the study, including our national coordinating center.)
First Posted : November 15, 2018
Last Update Posted : March 16, 2020
Sponsor:
Information provided by (Responsible Party):
Theraclion

Brief Summary:
This is a multi-center, crossover study with cluster randomization and a planned accrual of 300 patients with diagnosed breast fibroadenoma (One fibroadenoma treated per patient). This is a trial based prospective cost consequence study. Costs will be estimated from the viewpoint of the healthcare system and from the patient's perspective

Condition or disease Intervention/treatment Phase
Breast Fibroadenoma Procedure: Surgery Device: HIFU (Echopulse) Not Applicable

Detailed Description:

Fibroadenomas are well-circumscribed benign tumors, easily distinguishable from adjacent normal breast tissue on ultrasound images.

The goal of this protocol is to compare HIFU and surgery in terms of cost, safety, and clinical effectiveness for the treatment of nonmalignant breast tumors.

Fibroadenomas appear to be an ideal target for evaluation of ultrasound guided HIFU treatment. However, not all the FA are suitable for surgical treatment and in many cases surveillance associated or not with hormonal medication may be sufficient for limiting the symptoms at the degree compatible with a good quality of life for the patients. In addition, from the fraction of the patients for which ablation is a genuine medical need due to the severity of the pathology (size, symptoms, disturbed daily activity with possible psychological impact), only a part of them are suitable for undergoing the HIFU treatment.

Therefore, all the patients to be included in this study have an initial indication of surgical resection of the adenoma. Unlike the patients presenting FA and suitable for medication and surveillance, the cases for which surgery is an indication are symptomatic (significant pain, discomfort, anxiety) and/or are presenting a growth observed during their surveillance with ultrasound examination. In addition, all the eligible patients will have to comply with the technical limitations of the HIFU method in terms of lump size, subcutaneous depth, presence of calcifications and other contraindications like presence of breast implants or under areolar location. Knowing that after the age of 45 years the lumps are in many institutions reserved exclusively for surgery in order to eliminate all suspicion of malignancy, the upper age limit is fixed at 45. Further limitations as established by the American Society of Breast Surgeons for potential candidates of percutaneous excision will be added as inclusion criteria for all patients (the lesion must be sonographically visible, the diagnosis of FA must be confirmed histologically, lesions should be less than 4cm in largest diameter).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This is a multicentrer, crossover study with cluster randomization. In the cross over design, 1/2 of the centers are randomized to start the trial with HIFU and the other 1/2 with surgery. In the cluster randomized crossover (CXRO), all participating cluster receive both the intervention and control in a sequence determined at random
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU) vs Surgery: A Prospective Randomized Study
Actual Study Start Date : June 11, 2018
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : April 30, 2019

Arm Intervention/treatment
Active Comparator: Surgery
Surgery
Procedure: Surgery
Traditional open excisional surgery

Active Comparator: HIFU (Echopulse)
HIFU (Echopulse)
Device: HIFU (Echopulse)
High intensity focused ultrasound (HIFU) non invasive intervention




Primary Outcome Measures :
  1. Evaluation of the treatment of breast fibroadenoma by HIFU compared to surgery assessing the total induced cost in both study arms [ Time Frame: From day of treatment (Day0) to 18 months after treatment ]
    Difference in cost between the HIFU procedure and conventional surgery


Secondary Outcome Measures :
  1. Evaluation of the clinical effectiveness in both arms : Pain level assessment [ Time Frame: From 1 day after treatment (Day1) to 18 months after treatment ]
    Visual analog scale

  2. Evaluation of the clinical effectiveness in both arms: Anxiety level assessment [ Time Frame: From 1 day after treatment (Day1) to 18 months after treatment ]
    Visual analog scale

  3. Evaluation of the clinical effectiveness in both arms: Volume assessment [ Time Frame: From 1 day after treatment (Day1) to 18 months after treatment ]
    Ultrasound measurement

  4. Number of cases needing corrective surgery in case of lack of effectiveness of the primary HIFU treatment. [ Time Frame: From 1 day after treatment (Day1) to 18 months after treatment ]
    Rate of corrective surgical procedure after non effective HIFU procedure up to 18 months

  5. Safety of the procedures in both arms: Number of and severity of adverse events in both arms [ Time Frame: From day of treatment (Day0) to 18 months after treatment ]
    Number of and severity of adverse events in both arms



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female patients 18 to 45 years old with at least one diagnosed breast fibroadenoma
  • Diagnosis of fibroadenoma must be based on:

    • clinical examination
    • 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 less than 3. In all cases where an uncertainly exists, the patient will not be included.
    • histological confirmation after core needle biopsy by two independant readers (biopsy must be performed at least two weeks before therapy unless a micro biopsy has been already done less than 3 months before inclusion visit and histopathology slices are available)
  • the requirements for the distance from the skin and the following régions of the fibroadenoma are:

    • depth anterior edge < 19.4mm
    • nodule thickness > 7.3 mm
    • depth of posterior edge > 12.5 mm
    • depth to rib cage > 10mm
  • patient's fibroadenoma size is greater to equal to 0.3 cc (measured by ultrasound on the day of the procedure)
  • Lesions should be less than 20 mL
  • The lesion must be sonographically visible
  • Lesions presented during previous surveillance a minimum 20% increase volume AND/OR
  • Patient are presenting a pain level >= 3 as meaured on the VAS during the last 30 days AND/OR
  • Patient are presenting a anxiety level >= 3 as meaured on the VAS during the last 30 days before selection visit
  • Fibroadenoma is palpable
  • Patient candidate for sugery
  • Patient has signed a written informed consent
  • Patient with a social security coverage

Exclusion Criteria:

  • Patient is pregnant or lactating
  • Patient with history of laser or radiotherapy in the targeted breast
  • Core biopsy diagnosis suggestive of cytosarcoma phyllodes tumor or other malignancy
  • Patient with breast implant in the targeted breast
  • Patient with predominantly liquid nodule
  • Macro-calcifications in pre-focal HIFU path
  • Nipple and or areola in pre-focal HIFU path
  • Patient's fibroadenoma not clearly visible on the ultrasound images (in B-mode) at the inclusion visit
  • Scars or moles before the focal point of the HIFU
  • Patient participating in another clinical trial involving an investigational drug, or device

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): NCT03742401


Locations
Layout table for location information
France
Hopital Européen
Marseille, France, 13003
CHU de Montpellier
Montpellier, France, 34925
Polyclinique Majorelle
Nancy, France, 54000
Polyclinique de l'Atlantique
Nantes, France, 44819
American Hospital of Paris
Neuilly-sur-Seine, France, 92200
Hopital Saint Louis
Paris, France, 75010
Groupe Hospitaliler Diaconesses
Paris, France, 75012
Hopital Pitié-salpêtrière
Paris, France, 75651
Hopital TENON
Paris, France, 75970
Clinique Mutualiste LA SAGESSE
Rennes, France, 35043
CHU Strasbourg
Strasbourg, France, 67091
Centre Hospitalier
Valenciennes, France, 59300
Sponsors and Collaborators
Theraclion
Investigators
Layout table for investigator information
Principal Investigator: Richard Villet, PI Groupe Hospitaliler Diaconesses
Layout table for additonal information
Responsible Party: Theraclion
ClinicalTrials.gov Identifier: NCT03742401    
Other Study ID Numbers: HIFU-Surg-FA
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: March 16, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Theraclion:
Breast Fibroadenoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Fibroadenoma
Neoplasms, Fibroepithelial
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial