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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient without breast lump | Active Comparator | No breast lump identified during mammography (ACR 1 et 2 Birads classification) |
|
| Patient with breast lump | Experimental | Suspicious breast lump identified during mammography (ACR 4b, c ou ACR 5 Birads classification) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phi-Bra prototype measurements | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The day of inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| impedance optimal threshold | Determination of the impedance optimal threshold to detect breast lump in term of specificity and sensitivity (in Ohms) | The day of inclusion |
| Correlation between lump volume and device impedance |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Marion CORTET, MD, PhD | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Gynecologie-Obstetrique, Hopital de la Croix Rousse | Lyon | 69004 | France | |||
| Service de Radiologie, Hôpital de la Croix-Rousse |
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|
| The day of inclusion |
| Lyon |
| 69004 |
| France |