Breast Cancer FemaleBRIFUNCT03342625
High Intensity Focused Ultrasound Treatment of Breast Tumors. BRIFU Study
A study testing High Instensity Focused Ultrasound in people with Breast Cancer Female, run by Institut Bergonié at 1 site in France.
Trial summary
Monocentric prospective study evaluating the efficacy of High intensity focused ultrasound (HIFU) in breast tumors. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- High Instensity Focused Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jun 2018to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven infiltrating ductal carcinoma with the analysis of hormone receptors, tumor grade, Her-2 expression.
- T0 lesion, unifocal or plurifocal, with or without micro-calcifications associated, measuring 15 mm maximum major axis on ultrasound.
- Clinical N0.
- Bra cup size greater than or equal to B.
- Markable and identifiable lesion in MRI.
- Indication of partial or total mastectomy in case of multifocal lesions or extensive calcification associated with axillary surgery.
- Breast assessment performed by a referent radiologist: Mammography, ultrasound, clinical examination.
- No contraindication to MRI.
Who cannot join
- Infiltrating lobular carcinoma and Pure ductal carcinoma in situ.
- Bilateral lesion.
- Non-detectable MRI lesions, within 10 mm of the skin, greater than 15 mm on ultrasound.
- Unifocal palpable tumor.
- Cup size bra equal to A.
- Cutaneous lesion on the breast to be treated by HIFU.
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- Impossibility of ventral decubitus immobility, extended arm, during 1 hour.
- Pregnant or postpartum patient.
- Patient participating in another interventional clinical trial within 30 days of enrollment and during the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Simone MATHOULIN-PELISSIER, MD, PhD contact
France1 site, 1 recruiting
- Recruiting
Institut Bergonie
Bordeaux, 33076
Jean PALUSSIERE, MD, +33 5 56 33 37 50, j.palussiere@bordeaux.unicancer.fr
Christine TUNON DE LARA, MD, +33 5 56 33 33 35, c.tunondelara@bordeaux.unicancer.fr
About this study
Official title: High Intensity Focused Ultrasound Treatment of Breast Tumors. BRIFU Study (Breast Resection By HIFU)
Monocentric prospective study evaluating the efficacy of High intensity focused ultrasound (HIFU) in breast tumors.
Read the detailed description
Incidence of breast cancer increases with the lifetime of the population, and represents an important socio-economic issue. Diagnosis and treatment are major public health issues. High Instensity Focused Ultrasound (HIFU) is a minimally invasive technique which decreases the risk of post-treatment complications and allows shorter hospitalization times. This technology is also remarkable for the absence of limitation related to the dose delivered, which makes it possible to repeat if necessary and the absence of ionizing radiation both for the treatment itself and for its guidance (MRI).
The main objective is to evaluate the efficacy of HIFU for the treatment of breast tumors, based on histological criteria.
Indication :
Histologically invasive ductal carcinoma, T0, with unifocal or plurifocal lesion, with or without associated microcalcifications, measuring 15 mm maximum on ultrasound and clinical N0.
Course of the study :
- Signature of consent,
- Clinical and radiological assessment at Baseline,
- Realization of the HIFU procedure under local anesthesia and sedation (J0),
- Total or partial mastectomy depending on the lesion (between D2 and D8),
- Consultation with surgeon (J30),
Number of patients :
15 patients will be included in this pilot study. If no success is observed, the study will be stopped and the technique considered inefficient. If there are one or more successes, an Independant Data Monitoring Committee (IDMC) will meet to propose an additional trial if necessary with the data from this trial.
- Conditions
- Breast Cancer Female
- Being tested
- High Instensity Focused Ultrasound
- Keywords
- High intensity focused ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Instensity Focused UltrasoundDevice
Also called HIFU
High Intensity Focused Ultrasound guided by MRI
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Focused Ultrasound | Experimental | High Intensity Focused Ultrasound for the treatment of breast tumors, guided by MRI Receives: Device: High Instensity Focused Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of HIFU for the treatment of breast tumors, based on histological criteria
- Complete success: absence of viable invasive tumor cells on histological analysis.
- Incomplete success: Partial tumor destruction of the invasive contingent, unhealthy margins due to underestimation of tumor volume before treatment or imperfect targeting of focused ultrasound. Incomplete successes will be considered as failures. The persistence of an in situ quota alone will be considered as success.
- Failure: presence of viable invasive tumor cells in the treated area.
Measured: Day 30
Secondary outcomes (3)
Feasibility of non-invasive pre-surgical identification of the tumor area to be resected (palpation by the surgeon of the focused ultrasound ablation zone)
Measured: Day 2, 8
Immediate complications of focused ultrasound
Measured: Day 30
Pain (visual analogue scale) experienced by patients during the sedation procedure, until surgery.
Measured: Day 0, 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start7 Jun 2018
- Primary completionJun 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Collaborators
- Ligue contre le cancer, France
- Responsible party
- Sponsor
- Investigators
- Jean PALUSSIERE, MD, Study chair, Institut Bergonié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03342625
- Sponsor's protocol ID
- IB 2015-01
- Other IDs
- ID-RCB number : 2017-A01490-53
- Acronym
- BRIFU
- Status last verified
- Oct 2025
- First submitted
- 9 Nov 2017
- Last updated
- 2 Oct 2025
- 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 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Focused Ultrasound Treatment of Breast Tumors. BRIFU Study (Breast Resection By HIFU)
- ClinicalTrials.gov ID
- NCT03342625
- Acronym / sponsor ID
- BRIFU / IB 2015-01
- Conditions
- Breast Cancer Female
- Keywords
- High intensity focused ultrasound
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Collaborators
- Ligue contre le cancer, France
- Study start
- 7 Jun 2018 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 17 Nov 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.
Monocentric prospective study evaluating the efficacy of High intensity focused ultrasound (HIFU) in breast tumors.
Detailed description
Incidence of breast cancer increases with the lifetime of the population, and represents an important socio-economic issue. Diagnosis and treatment are major public health issues. High Instensity Focused Ultrasound (HIFU) is a minimally invasive technique which decreases the risk of post-treatment complications and allows shorter hospitalization times. This technology is also remarkable for the absence of limitation related to the dose delivered, which makes it possible to repeat if necessary and the absence of ionizing radiation both for the treatment itself and for its guidance (MRI).
The main objective is to evaluate the efficacy of HIFU for the treatment of breast tumors, based on histological criteria.
Indication :
Histologically invasive ductal carcinoma, T0, with unifocal or plurifocal lesion, with or without associated microcalcifications, measuring 15 mm maximum on ultrasound and clinical N0.
Course of the study :
- Signature of consent,
- Clinical and radiological assessment at Baseline,
- Realization of the HIFU procedure under local anesthesia and sedation (J0),
- Total or partial mastectomy depending on the lesion (between D2 and D8),
- Consultation with surgeon (J30),
Number of patients :
15 patients will be included in this pilot study. If no success is observed, the study will be stopped and the technique considered inefficient. If there are one or more successes, an Independant Data Monitoring Committee (IDMC) will meet to propose an additional trial if necessary with the data from this trial.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High Intensity Focused Ultrasound | Experimental | Device: High Instensity Focused UltrasoundHigh Intensity Focused Ultrasound for the treatment of breast tumors, guided by MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically proven infiltrating ductal carcinoma with the analysis of hormone receptors, tumor grade, Her-2 expression.
- T0 lesion, unifocal or plurifocal, with or without micro-calcifications associated, measuring 15 mm maximum major axis on ultrasound.
- Clinical N0.
- Bra cup size greater than or equal to B.
- Markable and identifiable lesion in MRI.
Key exclusion criteria (9 listed)
- Infiltrating lobular carcinoma and Pure ductal carcinoma in situ.
- Bilateral lesion.
- Non-detectable MRI lesions, within 10 mm of the skin, greater than 15 mm on ultrasound.
- Unifocal palpable tumor.
- Cup size bra equal to A.
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 Instensity Focused UltrasoundAlso: HIFUHigh Intensity Focused Ultrasound guided by MRI | Device | High Intensity Focused Ultrasound |
Primary outcome
Efficacy of HIFU for the treatment of breast tumors, based on histological criteria
Time frame: Day 30
* Complete success: absence of viable invasive tumor cells on histological analysis. * Incomplete success: Partial tumor destruction of the invasive contingent, unhealthy margins due to underestimation of tumor volume before treatment or imperfect targeting of focused ultrasound. Incomplete successes will be considered as failures. The persistence of an in situ quota alone will be considered as success. * Failure: presence of viable invasive tumor cells in the treated area.
3 secondary outcomes
Feasibility of non-invasive pre-surgical identification of the tumor area to be resected (palpation by the surgeon of the focused ultrasound ablation zone)
Time frame: Day 2, 8
Immediate complications of focused ultrasound
Time frame: Day 30
Pain (visual analogue scale) experienced by patients during the sedation procedure, until surgery.
Time frame: Day 0, 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- 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.
Simone MATHOULIN-PELISSIER, MD, PhD contact
Jean PALUSSIERE, MD study chair
Institut Bergonié
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 Instensity Focused Ultrasound in people with Breast Cancer Female, run by Institut Bergonié 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 8 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 2 Oct 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean PALUSSIERE, MD (+33 5 56 33 37 50, j.palussiere@bordeaux.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of HIFU for the treatment of breast tumors, based on histological criteria (time frame: Day 30). 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 2 Oct 2025.