Breast CancerMRHEATBREASTNCT03126487
High Intensity Focused Ultrasound Guided by MRI as Thermic Destruction in Primitive Small Size Breast Cancer
A study testing HIGH INTENSITY FOCUSED ULTRASOUND in people with Breast Cancer, run by Centre Antoine Lacassagne at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- HIGH INTENSITY FOCUSED ULTRASOUND
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 25 Apr 2017to 11 Jan 2018
- 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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman with invasive unifocal and unilateral noninflammatory ductal breast cancer.
- Age> 18 years.
- Size ≤ 10 mm (measured by MRI).
- Histological confirmation of breast cancer by biopsy with sufficient material to estimate grade, hormonal status and HER2 status.
- Lesion well delineated in MRI after injection of gadolinium and certain ultrasound correlation with the biopsy lesion.
- Distance> 10 mm between the tumor and the skin and between the tumor and the muscle.
Show all 11Show fewer
- Performance status 0 or 1
- 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
- Informing the patient or her legal representative and signing the informed consent
- Patient with Health care insurance available
Who cannot join
- Invasive lobular carcinoma or extensive in-situ component or only presence of micro-calcifications as a disease sign
- MRI or uncorrelated ultrasound lesion
- Distance <10 mm between the tumor and the skin or nipple or chest cage or muscle
- PS <2
- Patient weighing more than 110 Kg
- Breast Implants
Show all 12Show fewer
- History of breast irradiation
- History of surgery on the breast to be treated (fibrous scar, staples or surgical clips)
- Treatment with antiaromatase, tamoxifen or neoadjuvant chemotherapy within 30 days of treatment start
- History of severe cerebrovascular disease (cerebrovascular accident within 6 months prior to inclusion) or hemolytic anemia (hematocrite <30)
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- HIGH INTENSITY FOCUSED ULTRASOUND
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIGH INTENSITY FOCUSED ULTRASOUNDProcedure or surgery
HIGH INTENSITY FOCUSED ULTRASOUND GUIDED BY MRI AS THERMIC DESTRUCTION
| Study group | Role | What they receive |
|---|---|---|
| HIGH INTENSITY FOCUSED ULTRASOUND | Experimental | HIGH INTENSITY FOCUSED ULTRASOUND Receives: Procedure: HIGH INTENSITY FOCUSED ULTRASOUND |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological analysis of the surgical specimen will identify the tissue destroyed by ultrasound, residual healthy tissue and possibly residual viable cancerous tissue.
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
Measured: up to 24 months
Secondary outcomes (2)
Early skin toxicity is assessed until surgery
clinical examination (radiation oncologist) using NCI-CTCAE version 4.03 for erythema, telangiectasia and edema,
Measured: 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.
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.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start25 Apr 2017
- Primary completion11 Jan 2018
- Study completion11 Jan 2018
Why it stopped: study do not start due to concurrential trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Antoine Lacassagne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CHRISTINE LOVERA, MRS, Study director, CENTRE ANTOINE LACSSAGNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126487
- Sponsor's protocol ID
- 2015/36
- Acronym
- MRHEATBREAST
- Status last verified
- Jan 2018
- First submitted
- 12 Apr 2017
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Focused Ultrasound Guided by MRI as Thermic Destruction in Primitive Small Size Breast Cancer. Phase II Pilot Study : Effectiveness and Procedures Standardization
- ClinicalTrials.gov ID
- NCT03126487
- Acronym / sponsor ID
- MRHEATBREAST / 2015/36
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study do not start due to concurrential trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Antoine LacassagneUniversity, hospital or other
- Study start
- 25 Apr 2017 (actual)
- Primary completion
- 11 Jan 2018 (actual)
- Study completion
- 11 Jan 2018 (actual)
- First posted
- 24 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIGH INTENSITY FOCUSED ULTRASOUND | Experimental | Procedure: HIGH INTENSITY FOCUSED ULTRASOUNDHIGH INTENSITY FOCUSED ULTRASOUND |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Woman with invasive unifocal and unilateral noninflammatory ductal breast cancer.
- Age> 18 years.
- Size ≤ 10 mm (measured by MRI).
- Histological confirmation of breast cancer by biopsy with sufficient material to estimate grade, hormonal status and HER2 status.
- Lesion well delineated in MRI after injection of gadolinium and certain ultrasound correlation with the biopsy lesion.
Key exclusion criteria (12 listed)
- Invasive lobular carcinoma or extensive in-situ component or only presence of micro-calcifications as a disease sign
- MRI or uncorrelated ultrasound lesion
- Distance <10 mm between the tumor and the skin or nipple or chest cage or muscle
- PS <2
- Patient weighing more than 110 Kg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIGH INTENSITY FOCUSED ULTRASOUNDHIGH INTENSITY FOCUSED ULTRASOUND GUIDED BY MRI AS THERMIC DESTRUCTION | Procedure or surgery | HIGH INTENSITY FOCUSED ULTRASOUND |
Primary outcome
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
2 secondary outcomes
Early skin toxicity is assessed until surgery
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.
Time frame: up to 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CHRISTINE LOVERA, MRS study director
CENTRE ANTOINE LACSSAGNE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIGH INTENSITY FOCUSED ULTRASOUND in people with Breast Cancer, run by Centre Antoine Lacassagne at 1 site 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 11 inclusion and 12 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: withdrawn, as of the sponsor's last update on 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 withdrawn before enrolling participants, so there are no results.
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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2018.