Phi-Bra is a prospective and monocentric pilot study to assess the diagnostic capability of an innovative bra prototype to detect breast cancer, compared to the current standard of care: the mammography. The Phi-Bra prototype is designed with sensors measuring different parameters simultaneously such as impedance and temperature. The bra will be tested on patients without breast lump (American College of Radiology (ACR) 1 et 2 Birads classification) and with breast lump (ACR 4b, c ou ACR 5 Birads classification). The aim of this pilot study is to compare the results obtained by Phi-Bra to the ones obtained by mammography. The Phi-Bra study is classified as clinical investigation category 4.4 based on the European Union (EU) regulation (DM 2017/745).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
45
The bra prototype will be placed on the patient's breast. The patient will stay in a half-lying position during 15 min, the time duration of the measurements. Measurements will not be painful. Measurements will only be realized one time during the first and unique visit of the patient.
Service de Gynecologie-Obstetrique, Hopital de la Croix Rousse
Lyon, France
Service de Radiologie, Hôpital de la Croix-Rousse
Lyon, France
Aria Under Receiver Operating Characteristic (ROC) Curve
The diagnostic performance of Phi-Bra to assess breast lump will be assessed by evaluating the ROC Area Under Curve (AUC), the reference being mammography as gold standard.
Time frame: The day of inclusion
impedance optimal threshold
Determination of the impedance optimal threshold to detect breast lump in term of specificity and sensitivity (in Ohms)
Time frame: The day of inclusion
Correlation between lump volume and device impedance
Time frame: The day of inclusion
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