Breast Neoplasm Female
Conditions
Keywords
Breast cancer detection, impedance
Brief summary
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).
Interventions
DEVICEPhi-Bra prototype measurements
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.
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 75. * No breast cancer surgery background * Bra size : S/M or M/L Specific criteria for the no breast lump cohort: \- Negative mammography result (ACR 1 a 2). Specific criteria for the breast lump cohort: \- Suspicious breast lump discovered during the mammography (ACR 4b ou c ou ACR 5) and for which there is an indication of microbiopsy.
Exclusion criteria
* Breast cancer background (surgery or radiotherapy) * Breast lump classified as ACR 3 ou ACR 4a during the mammography
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aria Under Receiver Operating Characteristic (ROC) Curve | The day of inclusion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| impedance optimal threshold | The day of inclusion | Determination of the impedance optimal threshold to detect breast lump in term of specificity and sensitivity (in Ohms) |
| Correlation between lump volume and device impedance | The day of inclusion | — |
Countries
France
Outcome results
None listed