This study is a multicentre, open, uncontrolled trial for the observation of histological changes in breast fibroadenoma following high intensity focused ultrasound (HIFU). This study will be conducted in France in 20 patients with breast fibroadenoma with indication for a surgical resection. The patient will receive an HIFU treatment and 6 months after treatment, the need of the surgery is evaluated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
High Intensity focused ultrasound treatment
Hôpital Jeanne de Flandre, CHU de Lille 2 Avenue Oscar Lambret
Lille, France
Hôpital Américain de Paris
Neuilly-sur-Seine, France
HIFU induced tissue necrosis assessed by histology of excised gland or reduction volume of fibroadenoma
Time frame: 6 months after HIFU treatment
Volume reduction of the fibroadenoma
reduction in volume at 2, 4, 6 and 12 months after HIFU session or total regression of the fibroadenoma evaluated with ultrasound just before surgery
Time frame: 12 months after HIFU treatment
- Pain score during the HIFU treatment evaluated by the Visual Analog Scale.
Time frame: at treatment
Percentage of patients with Adverse events
Time frame: at 12 months follow-up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.