High Intensity Focused Ultrasound for Breast Cancer
High Intensity Focused Ultrasound Treatment of Breast Tumors. BRIFU Study
Recruiting
N/AInterventional Study
Breast Cancer Female
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Other
Participants needed
15 (estimated)
Sponsor
Institut Bergonié · Other
Who this trial is looking for
This trial is looking for women with breast cancer who have a specific type of tumor. If you join, you may receive treatment using High Intensity Focused Ultrasound to help with your condition.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with infiltrating ductal carcinoma.
My breast tumor is 15 mm or smaller on ultrasound.
I have no signs of cancer in my lymph nodes.
I wear a bra size B or larger.
I have an identifiable lesion visible on MRI.
I've had a breast assessment with mammography, ultrasound, and clinical exam.
I have no contraindications for MRI.
You may not be able to join if
I have infiltrating lobular carcinoma or pure ductal carcinoma in situ.
I have a lesion on both of my breasts.
My MRI lesions are not visible or too close to the skin.
I have a palpable tumor that is unifocal.
I wear a bra size A.
I have a skin lesion on the breast that needs treatment.
I cannot lie still on my stomach with my arm extended for 1 hour.
I am pregnant or recently gave birth.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Monocentric prospective study evaluating the efficacy of High intensity focused ultrasound (HIFU) in breast tumors.
Trial Locations
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Eligibility Criteria
Inclusion Criteria :
1. Histologically proven infiltrating ductal carcinoma with the analysis of hormone receptors, tumor grade, Her-2 expression.
2. T0 lesion, unifocal or plurifocal, with or without micro-calcifications associated, measuring 15 mm maximum major axis on ultrasound.
3. Clinical N0.…
Inclusion Criteria :
1. Histologically proven infiltrating ductal carcinoma with the analysis of hormone receptors, tumor grade, Her-2 expression.
2. T0 lesion, unifocal or plurifocal, with or without micro-calcifications associated, measuring 15 mm maximum major axis on ultrasound.
3. Clinical N0.
4. Bra cup size greater than or equal to B.
5. Markable and identifiable lesion in MRI.
6. Indication of partial or total mastectomy in case of multifocal lesions or extensive calcification associated with axillary surgery.
7. Breast assessment performed by a referent radiologist: Mammography, ultrasound, clinical examination.
8. No contraindication to MRI.
Exclusion Criteria :
1. Infiltrating lobular carcinoma and Pure ductal carcinoma in situ.
2. Bilateral lesion.
3. Non-detectable MRI lesions, within 10 mm of the skin, greater than 15 mm on ultrasound.
4. Unifocal palpable tumor.
5. Cup size bra equal to A.
6. Cutaneous lesion on the breast to be treated by HIFU.
7. Impossibility of ventral decubitus immobility, extended arm, during 1 hour.
8. Pregnant or postpartum patient.
9. Patient participating in another interventional clinical trial within 30 days of enrollment and during the trial.
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