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

NCT03742401 | Terminated

• 1 other identifier: HIFU-Surg-FA
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 12

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

Conditions

Breast Fibroadenoma

Keywords

Breast Fibroadenoma

Outcome Measures

Primary Outcomes (1)

• Evaluation of the treatment of breast fibroadenoma by HIFU compared to surgery assessing the total induced cost in both study arms

  Difference in cost between the HIFU procedure and conventional surgery

  From day of treatment (Day0) to 18 months after treatment

Secondary Outcomes (5)

• Evaluation of the clinical effectiveness in both arms : Pain level assessment

  From 1 day after treatment (Day1) to 18 months after treatment

• Evaluation of the clinical effectiveness in both arms: Anxiety level assessment

  From 1 day after treatment (Day1) to 18 months after treatment

• Evaluation of the clinical effectiveness in both arms: Volume assessment

  From 1 day after treatment (Day1) to 18 months after treatment

• Number of cases needing corrective surgery in case of lack of effectiveness of the primary HIFU treatment.

  From 1 day after treatment (Day1) to 18 months after treatment

• Safety of the procedures in both arms: Number of and severity of adverse events in both arms

  From day of treatment (Day0) to 18 months after treatment

Study Arms (2)

Surgery

ACTIVE COMPARATOR

Surgery

Procedure: Surgery

HIFU (Echopulse)

ACTIVE COMPARATOR

HIFU (Echopulse)

Device: HIFU (Echopulse)

Interventions

Surgery PROCEDURE

Traditional open excisional surgery

Surgery

HIFU (Echopulse) DEVICE

High intensity focused ultrasound (HIFU) non invasive intervention

HIFU (Echopulse)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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
• Scars or moles before the focal point of the HIFU
• Patient participating in another clinical trial involving an investigational drug, or device

Sponsors & Collaborators

• Theraclion: lead

Study Sites (12)

Hopital Européen

Marseille, 13003, France

Location

CHU de Montpellier

Montpellier, 34925, France

Location

Polyclinique Majorelle

Nancy, 54000, France

Location

Polyclinique de l'Atlantique

Nantes, 44819, France

Location

American Hospital of Paris

Neuilly-sur-Seine, 92200, France

Location

Hopital Saint Louis

Paris, 75010, France

Location

Groupe Hospitaliler Diaconesses

Paris, 75012, France

Location

Hopital Pitié-salpêtrière

Paris, 75651, France

Location

Hopital TENON

Paris, 75970, France

Location

Clinique Mutualiste LA SAGESSE

Rennes, 35043, France

Location

CHU Strasbourg

Strasbourg, 67091, France

Location

Centre Hospitalier

Valenciennes, 59300, France

Location

MeSH Terms

Conditions

Fibroadenoma

Interventions

Surgical Procedures, Operative

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

• Richard Villet, PI

  Groupe Hospitaliler Diaconesses

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: November 15, 2018
• Study Start: June 11, 2018
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: March 16, 2020

Record last verified: 2019-12

Locations

FR (12)