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

Breast Neoplasm Female Clinical Trial

— Phi-Bra  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05574816
• Other study ID #: 69HCL21_1085
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2023
• Est. completion date: August 30, 2023

Study information

• Verified date: April 2023
• Source: Hospices Civils de Lyon
• Contact: Marion CORTET, MD, PhD
• Phone: +33 4 27 85 40 78
• Email: marion.cortet[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 41
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasm Female
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	Service de Gynecologie-Obstetrique, Hopital de la Croix Rousse	Lyon
France	Service de Radiologie, Hôpital de la Croix-Rousse	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Correlation between lump volume and device impedance		The day of inclusion