Smart Optical and Ultrasound Diagnostic of Breast Cancer (SOLUS)
Breast Disease
About this trial
This is an interventional diagnostic trial for Breast Disease
Eligibility Criteria
Inclusion Criteria: women over 18 years of age subject with a breast lesion visible at US, either: benign, classified as benign lesions at previous US and unchanged for at least 2 years or with a previous core biopsy done at least 1 year before or BI-RADS 2 or 3, confirmed at histology after SOLUS examination or malignant, classified as BI-RADS 4 or 5, confirmed at histology after SOLUS examination Exclusion Criteria: subject is pregnant, breast feeding subject is unable or unwilling to give informed consent previous core biopsy of the same breast, performed in the last year previous breast surgery of the same breast
Sites / Locations
- Ospedale San RaffaeleRecruiting
Arms of the Study
Arm 1
Experimental
SOLUS examination arm
At least 40 adult women, 20 with malignant and 20 with benign breast lesions visible at US examination, aged over 18 years, will be included.