Evaluation of the Diagnostic Performance of a Bra Prototype to Detect Breast Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 45
- Locations
- 2
- Primary Endpoint
- Aria Under Receiver Operating Characteristic (ROC) Curve
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age between 18 and
- •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
Arms & Interventions
Patient without breast lump
No breast lump identified during mammography (ACR 1 et 2 Birads classification)
Intervention: Phi-Bra prototype measurements (Device)
Patient with breast lump
Suspicious breast lump identified during mammography (ACR 4b, c ou ACR 5 Birads classification)
Intervention: Phi-Bra prototype measurements (Device)
Outcomes
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(The day of inclusion)
- Correlation between lump volume and device impedance(The day of inclusion)