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

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).

Completed

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Key information

Conditions

Breast Neoplasm Female

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Aria Under Receiver Operating Characteristic (ROC) Curve

Time frame: 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 outcomes

impedance optimal threshold

Time frame: 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

Time frame: The day of inclusion

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: Phi-Bra

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Oct 12, 2022
Registry last updated: Jun 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed