High Intensity Focused Ultrasound Guided by MRI as Thermic Destruction in Primitive Small Size Breast Cancer (MRHEATBREAST)

January 26, 2018 updated by: Centre Antoine Lacassagne

High Intensity Focused Ultrasound Guided by MRI as Thermic Destruction in Primitive Small Size Breast Cancer. Phase II Pilot Study : Effectiveness and Procedures Standardization

This is a non-randomized, prospective phase II trial evaluating an innovative treatment, focused MRI-guided ultrasound, as thermic destruction in primitive small size breast cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Conservative Breast Treatment (BCT) :

The reference treatment for patients with stage T1 breast cancer is a partial mastectomy followed by radiotherapy (breast). This is a conservative treatment (BCT). Indeed, the survival results of this combined treatment are equivalent to those observed after a total mastectomy alone and is an aesthetically and psychologically more acceptable proposition for patients.

Adjuvant radiotherapy is an essential component of the success of conservative therapy most likely due to the impossibility of surgical treatment of removing all microscopically viable cancer cells. Indeed, in the absence of radiotherapy, partial mastectomy shows a local recurrence rate of 20-40% in case of N0 and 25-50% in case of N + on long-term follow-up data.

The results of the literature are very variable according to the length of the follow-up and the population studied but the adjuvant radiotherapy clearly allows to increase the rate of local control.

It reduces local recurrences to 10% at 12 years in the case of radiotherapy in the breast and 6% in case of boost on the tumor area.

The high sensitivity of breast MRI and emerging issues. The development of breast MRI revealed the incidental discovery of 10 to 40% of additional breast cancer in patients initially explored by mammography and ultrasound standards. These cancers discovered at early stages and of small size complicate the strategy of local management and incite to develop techniques alternative to the surgery.

Several minimally invasive treatments for the local treatment of breast cancers are being studied: BLES (Breast Lesion Excision Sample), cryotherapy, radiofrequency, laser and microwaves. Among them, focused ultrasound offers a completely non-invasive heat ablation technique.

High intensity focused ultrasound (FUS) and magnetic resonance imaging (MRI) guidance = FUS-MRI High intensity focused ultrasound thermal ablation is an attractive treatment modality for solid tumors because it does not require incision. Moreover, coupled with magnetic resonance, it offers precise targeting and control destruction.

An ablation procedure begins with the acquisition of a series of MRI images centered on the organ to be treated. The radiologist loads the images onto the processing machine and identifies the target volume to be destroyed by segmenting it from the MRI images. The console provides a treatment plan with the necessary parameters to efficiently process the defined region.

High intensity focussed ultrasonic destruction is possible due to the elevation of temperature at the focal point. By analogy, one can compare the technique to the use of a magnifying glass to focus the sun's rays and trigger a flame. In ultrasound diagnostic ultrasound is used without convergence of beams. In the therapeutic application, it is the focusing at a point and the use of high intensities which make it possible to deliver energy in the form of heat. This step is called "sonication". Sonication heats the tissue between 65 and 85 ° C in the well-defined region of the focal point and causes tissue thermo-coagulation.

MRI images acquired during heating allow real-time monitoring of the rise in temperature. This makes it possible to check the position of the sonication and the size of the zone thus coagulated. The sonications are thus repeated at multiple adjacent points to cover the prescribed ablation volume.

This combination of FUS-MRI has already shown convincing results on bone, prostate and uterine fibroid tumors, so the hypothesis is that it has a potential interest in the conservative treatment of breast cancer.

The Ex-Ablate 2000 system (trade name) It is a machine incorporating FUS-MRI technology. It consists of a high intensity focused ultrasound transducer mounted in the MRI examination table.

With its precision and unique ability to follow ablation, Ex-Ablate has been used in many tumor contexts and has demonstrated its ability to provide significant tumor destruction on small volumes.

On the breast, the system showed promising results in several Phase II protocols on the treatment of breast tumors with good aesthetic results and no major toxicity.

These arguments justify the choice of using Ex-Ablate as a means of thermic destruction for small size breast cancer.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France, 06189
        • Centre Antoine Lacassagne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Woman with invasive unifocal and unilateral noninflammatory ductal breast cancer.
  2. Age> 18 years.
  3. Size ≤ 10 mm (measured by MRI).
  4. Histological confirmation of breast cancer by biopsy with sufficient material to estimate grade, hormonal status and HER2 status.
  5. Lesion well delineated in MRI after injection of gadolinium and certain ultrasound correlation with the biopsy lesion.
  6. Distance> 10 mm between the tumor and the skin and between the tumor and the muscle.
  7. Performance status 0 or 1

  8. Biological exam according to the following standards:

    Neutrophiles> 1.5 x 109 / L Hemoglobin> 9 g / dL Plates> 100 x 109 / L ASAT - ALAT <2.5 x ULN Bilirubin <1.5 x ULN Creatinine <150 μmol / L and> 60 μmol / L Clearance> 30 ml / min

  9. Informing the patient or her legal representative and signing the informed consent
  10. Patient with Health care insurance available

Exclusion Criteria:

  1. Invasive lobular carcinoma or extensive in-situ component or only presence of micro-calcifications as a disease sign
  2. MRI or uncorrelated ultrasound lesion
  3. Distance <10 mm between the tumor and the skin or nipple or chest cage or muscle
  4. PS <2
  5. Patient weighing more than 110 Kg
  6. Breast Implants
  7. History of breast irradiation
  8. History of surgery on the breast to be treated (fibrous scar, staples or surgical clips)
  9. Treatment with antiaromatase, tamoxifen or neoadjuvant chemotherapy within 30 days of treatment start
  10. History of severe cerebrovascular disease (cerebrovascular accident within 6 months prior to inclusion) or hemolytic anemia (hematocrite <30)
  11. Patient with cardiac disorders (severe hypertension, antiarrhythmic treatments, history of cardiac ischemia) 1

2. Patient under dialysis 13. Patient under anti-coagulant treatment 14. Patient refusing surgery or for which surgery is contraindicated 15. Contraindication to the realization of MRI or thermo-ablation treatment 16. Patient has a contraindication to Gadolinium 17. Vulnerable persons are defined in Article L1121-5 to -8: Pregnant women, and nursing mothers, persons deprived of their liberty by a judicial or administrative decision, persons admitted without consent under Articles L. 3212-1 and L. 3213-1 who are not covered by the provisions Of Article L. 1121-8 and persons admitted to a health or social institution for purposes other than research Persons of legal age who are under protection or who are unable to give their consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: HIGH INTENSITY FOCUSED ULTRASOUND
Procedure: HIGH INTENSITY FOCUSED ULTRASOUND
HIGH INTENSITY FOCUSED ULTRASOUND GUIDED BY MRI AS THERMIC DESTRUCTION

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Histological analysis of the surgical specimen will identify the tissue destroyed by ultrasound, residual healthy tissue and possibly residual viable cancerous tissue.
Time Frame: up to 24 months
All surgical specimens will be collected and analyzed in full. The sterility of the surgical specimen will be assessed using the score proposed by the EORTC-STBSG (FUS-MRI) in the local treatment of infra-centimetric breast cancer by histological confrontation of the surgical specimen
up to 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Early skin toxicity is assessed until surgery
Time Frame: up to 24 months
clinical examination (radiation oncologist) using NCI-CTCAE version 4.03 for erythema, telangiectasia and edema,
up to 24 months
The quality of life will be measured before treatment on D0, and during the visit between D21 and D28 using the QLQ-C30 questionnaire - breast module BR23-version 3.
Time Frame: up to 24 months
The quality of life will be measured before treatment on D0, and during the visit between D21 and D28 using the QLQ-C30 questionnaire - breast module BR23-version 3.
up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Antoine Lacassagne

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: CHRISTINE LOVERA, MRS, CENTRE ANTOINE LACSSAGNE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 25, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 11, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 11, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 29, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015/36

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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