Back to resultsTreatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)
Primary Purpose
Breast Fibroadenoma
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Surgery
HIFU (Echopulse)
Sponsored by
About this trial
This is an interventional treatment trial for Breast Fibroadenoma focused on measuring Breast Fibroadenoma
Eligibility 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
Sites / Locations
- Hopital Européen
- CHU de Montpellier
- Polyclinique Majorelle
- Polyclinique de l'Atlantique
- American Hospital of Paris
- Hopital Saint Louis
- Groupe Hospitaliler Diaconesses
- Hopital Pitié-salpêtrière
- Hopital TENON
- Clinique Mutualiste LA SAGESSE
- CHU Strasbourg
- Centre Hospitalier
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Surgery
HIFU (Echopulse)
Arm Description
Surgery
HIFU (Echopulse)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Evaluation of the clinical effectiveness in both arms : Pain level assessment
Visual analog scale
Evaluation of the clinical effectiveness in both arms: Anxiety level assessment
Visual analog scale
Evaluation of the clinical effectiveness in both arms: Volume assessment
Ultrasound measurement
Number of cases needing corrective surgery in case of lack of effectiveness of the primary HIFU treatment.
Rate of corrective surgical procedure after non effective HIFU procedure up to 18 months
Safety of the procedures in both arms: Number of and severity of adverse events in both arms
Number of and severity of adverse events in both arms
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03742401
Brief Title
Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)
Official Title
Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU) vs Surgery: A Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Terminated
Why Stopped
Changes to the HIFU-SURG-FA study protocol, a number of centers have decided not to continue the study, including our national coordinating center.
Study Start Date
June 11, 2018 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theraclion
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Fibroadenoma
Keywords
Breast Fibroadenoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Surgery
Arm Type
Active Comparator
Arm Description
Surgery
Arm Title
HIFU (Echopulse)
Arm Type
Active Comparator
Arm Description
HIFU (Echopulse)
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
Traditional open excisional surgery
Intervention Type
Device
Intervention Name(s)
HIFU (Echopulse)
Intervention Description
High intensity focused ultrasound (HIFU) non invasive intervention
Primary Outcome Measure Information:
Title
Evaluation of the treatment of breast fibroadenoma by HIFU compared to surgery assessing the total induced cost in both study arms
Description
Difference in cost between the HIFU procedure and conventional surgery
Time Frame
From day of treatment (Day0) to 18 months after treatment
Secondary Outcome Measure Information:
Title
Evaluation of the clinical effectiveness in both arms : Pain level assessment
Description
Visual analog scale
Time Frame
From 1 day after treatment (Day1) to 18 months after treatment
Title
Evaluation of the clinical effectiveness in both arms: Anxiety level assessment
Description
Visual analog scale
Time Frame
From 1 day after treatment (Day1) to 18 months after treatment
Title
Evaluation of the clinical effectiveness in both arms: Volume assessment
Description
Ultrasound measurement
Time Frame
From 1 day after treatment (Day1) to 18 months after treatment
Title
Number of cases needing corrective surgery in case of lack of effectiveness of the primary HIFU treatment.
Description
Rate of corrective surgical procedure after non effective HIFU procedure up to 18 months
Time Frame
From 1 day after treatment (Day1) to 18 months after treatment
Title
Safety of the procedures in both arms: Number of and severity of adverse events in both arms
Description
Number of and severity of adverse events in both arms
Time Frame
From day of treatment (Day0) to 18 months after treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Villet, PI
Organizational Affiliation
Groupe Hospitaliler Diaconesses
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Européen
City
Marseille
ZIP/Postal Code
13003
Country
France
Facility Name
CHU de Montpellier
City
Montpellier
ZIP/Postal Code
34925
Country
France
Facility Name
Polyclinique Majorelle
City
Nancy
ZIP/Postal Code
54000
Country
France
Facility Name
Polyclinique de l'Atlantique
City
Nantes
ZIP/Postal Code
44819
Country
France
Facility Name
American Hospital of Paris
City
Neuilly-sur-Seine
ZIP/Postal Code
92200
Country
France
Facility Name
Hopital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Groupe Hospitaliler Diaconesses
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Hopital Pitié-salpêtrière
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Hopital TENON
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Clinique Mutualiste LA SAGESSE
City
Rennes
ZIP/Postal Code
35043
Country
France
Facility Name
CHU Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Centre Hospitalier
City
Valenciennes
ZIP/Postal Code
59300
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)
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