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

Not Applicable

Completed

• Conditions: Breast Neoplasm Female
• Interventions: Device: Phi-Bra prototype measurements

• Registration Number: NCT05574816
• Lead Sponsor: Hospices Civils de Lyon

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-07
• Study First Submitted QC: 2022-10-07
• Study First Posted: 2022-10-12
• Study Start: 2023-03-30
• Primary Completion: 2024-02-01
• Study Completion: 2024-02-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient without breast lump	Phi-Bra prototype measurements	No breast lump identified during mammography (ACR 1 et 2 Birads classification)
Patient with breast lump	Phi-Bra prototype measurements	Suspicious breast lump identified during mammography (ACR 4b, c ou ACR 5 Birads classification)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Service de Gynecologie-Obstetrique, Hopital de la Croix Rousse; 🇫🇷 Lyon, France

Service de Radiologie, Hôpital de la Croix-Rousse; 🇫🇷 Lyon, France