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

NCT05574816 | Completed

• 1 other identifier: 69HCL21_1085
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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).

Conditions

Breast Neoplasm Female

Keywords

Breast cancer detection; impedance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• impedance optimal threshold

  The day of inclusion

• Correlation between lump volume and device impedance

  The day of inclusion

Study Arms (2)

Patient without breast lump

ACTIVE COMPARATOR

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

Device: Phi-Bra prototype measurements

Patient with breast lump

EXPERIMENTAL

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

Device: Phi-Bra prototype measurements

Interventions

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.

Patient with breast lump; Patient without breast lump

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Breast cancer background (surgery or radiotherapy)
• Breast lump classified as ACR 3 ou ACR 4a during the mammography

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

Service de Gynecologie-Obstetrique, Hopital de la Croix Rousse

Lyon, 69004, France

Location

Service de Radiologie, Hôpital de la Croix-Rousse

Lyon, 69004, France

Location

Study Officials

• Marion CORTET, MD, PhD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 12, 2022
• Study Start: March 30, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)