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

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05574816

Collaborator

(none)

Enrollment

Locations

Arms

6.5

Anticipated Duration (Months)

40.5

Patients Per Site

6.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasm Female	Device: Phi-Bra prototype measurements	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

81 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Oct 15, 2022

Anticipated Primary Completion Date :

Apr 30, 2023

Anticipated Study Completion Date :

Apr 30, 2023

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service de Gynecologie-Obstetrique, Hopital de la Croix Rousse	Lyon		France	69004
2	Service de Radiologie, Hôpital de la Croix-Rousse	Lyon		France	69004

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT05574816

Other Study ID Numbers:

69HCL21_1085

First Posted:

Oct 12, 2022

Last Update Posted:

Oct 13, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hospices Civils de Lyon

Breast cancer detection

impedance

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Oct 13, 2022