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

Civil Hospices of Lyon

Status: Completed

Conditions: Breast Neoplasm Female

Treatments: Device: Phi-Bra prototype measurements

Study type: Interventional

Funder types: Other

Identifiers

NCT05574816

69HCL21_1085

Details and patient eligibility

About

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).

Enrollment: 45 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Patient without breast lump

Active Comparator group

Description:

No breast lump identified during mammography (ACR 1 et 2 Birads classification)

Treatment:

Device: Phi-Bra prototype measurements

Patient with breast lump

Experimental group

Description:

Suspicious breast lump identified during mammography (ACR 4b, c ou ACR 5 Birads classification)

Treatment:

Device: Phi-Bra prototype measurements