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Breast FibroadenomaNCT03742401

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

A study testing Surgery and HIFU (Echopulse) in people with Breast Fibroadenoma, run by Theraclion at 12 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Breast Fibroadenoma
What is being tested?
Surgery and HIFU (Echopulse)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
12 sitesFrance
Study dates
11 Jun 2018to 30 Apr 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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:
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

France12 sites

  • Hopital Européen

    Marseille, 13003

  • CHU de Montpellier

    Montpellier, 34925

  • Polyclinique Majorelle

    Nancy, 54000

  • Polyclinique de l'Atlantique

    Nantes, 44819

  • American Hospital of Paris

    Neuilly-sur-Seine, 92200

  • Hopital Saint Louis

    Paris, 75010

  • Groupe Hospitaliler Diaconesses

    Paris, 75012

  • Hopital Pitié-salpêtrière

    Paris, 75651

  • Hopital TENON

    Paris, 75970

  • Clinique Mutualiste LA SAGESSE

    Rennes, 35043

  • CHU Strasbourg

    Strasbourg, 67091

  • Centre Hospitalier

    Valenciennes, 59300

Other trials in France

About this study

Official title: Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU) vs Surgery: A Prospective Randomized Study

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

Read the 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).

Being tested
Surgery, HIFU (Echopulse)
Keywords
Breast Fibroadenoma
Medical subject headings
Fibroadenoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurgeryProcedure or surgery

    Traditional open excisional surgery

  • HIFU (Echopulse)Device

    High intensity focused ultrasound (HIFU) non invasive intervention

Study groups in NCT03742401
Study groupRoleWhat they receive
SurgeryActive comparatorSurgery
Receives: Procedure: Surgery
HIFU (Echopulse)Active comparatorHIFU (Echopulse)
Receives: Device: HIFU (Echopulse)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (5)

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

    Visual analog scale

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

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

    Visual analog scale

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

  3. Evaluation of the clinical effectiveness in both arms: Volume assessment

    Ultrasound measurement

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

  4. 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

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

  5. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2018
  2. Study start11 Jun 2018
  3. Primary completion30 Apr 2019
  4. Study completion30 Apr 2019

Why it 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
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)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03742401
Sponsor's protocol ID
HIFU-Surg-FA
Status last verified
Dec 2019
First submitted
12 Nov 2018
Last updated
16 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Surgery and HIFU (Echopulse) in people with Breast Fibroadenoma, run by Theraclion at 12 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Changes to the HIFU-SURG-FA study protocol, a number of centers have decided not to continue the study, including our national coordinating center.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03742401.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2020.

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