Evaluation of the Diagnostic Performance of a Bra Prototype to Detect Breast Cancer (Phi-Bra)

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 Overview

• Status: Completed
• Conditions: Breast Neoplasm Female
• Intervention / Treatment: Device: Phi-Bra prototype measurements

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Service de Gynecologie-Obstetrique, Hopital de la Croix Rousse
  • Lyon, France, 69004
    • Service de Radiologie, Hôpital de la Croix-Rousse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Marion CORTET, MD, PhD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2023
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: October 7, 2022
• First Submitted That Met QC Criteria: October 7, 2022
• First Posted (Actual): October 12, 2022

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 11, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Breast cancer detection; impedance
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 69HCL21_1085

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No