Smart Bra for Diagnosing Breast Cancer (CBRA)

February 24, 2026 updated by: Hopital Nord Franche-Comte

Smart Bra for Diagnosing Breast Cancer: Pilot Study - CBRA

This project aims to assess the ability of a portable and connected medical device to detect breast abnormalities, for breast cancer screening. It will accelerate technological progress in the face of breast cancer.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France
        • ICANS (Institut de Cancérologie de Strasbourg)
      • Trévenans, France
        • Hôpital Nord Franche-Comté

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Non-specific invasive carcinoma diagnosed by biopsy
  • X-ray images available
  • Tumor larger than 1 cm assessed radiologically and/or by ultrasound and/or clinically
  • Patient with a breast size compatible with the study bra size

Exclusion Criteria:

  • Contralateral breast cancer
  • Inflammatory breast cancer
  • History of cosmetic or plastic surgery (mastopexy, prosthesis, lipomodelling)
  • History of breast cancer or mastectomy
  • Presence of dermatological pathology or breast skin ulceration
  • Hematoma post biopsy
  • History of thoraco-abdominal radiotherapy
  • Known allergy to one of the materials of the device
  • Fever (body temperature > 37.8°C)
  • Pacemaker port

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control group
Device: BRA CONNECT device
skin thermal analysis for the detection of breast abnormalities
Other: Patient group
Device: BRA CONNECT device
skin thermal analysis for the detection of breast abnormalities

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the ability of the device to detect breast abnormalities or not, in healthy women or women with a non-specific invasive carcinoma diagnosed.
Time Frame: 20 minutes of recording
Sensitivity and specificity of the device to detect a breast abnormality
20 minutes of recording

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Nord Franche-Comte

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2022

Primary Completion (Actual)

July 10, 2025

Study Completion (Estimated)

August 28, 2026

Study Registration Dates

First Submitted

March 15, 2022

First Submitted That Met QC Criteria

March 15, 2022

First Posted (Actual)

March 24, 2022

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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