Evaluation of the Diagnostic Performance of a Bra Prototype to Detect Breast Cancer

Study Overview
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Brief Summary
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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).

Official Title
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Evaluation of the Diagnostic Performance of a Bra Prototype to Detect Breast Cancer

Conditions
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Breast Neoplasm Female

Intervention / Treatment
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* Device: Phi-Bra prototype measurements


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patient without breast lump<br>No breast lump identified during mammography (ACR 1 et 2 Birads classification) | Device: Phi-Bra prototype measurements<br>* 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.<br>|
| Experimental: Patient with breast lump<br>Suspicious breast lump identified during mammography (ACR 4b, c ou ACR 5 Birads classification) | Device: Phi-Bra prototype measurements<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | The day of inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer detection, impedance