Smart Bra for Diagnosing Breast Cancer

Hopital Nord Franche-Comte70 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Breast Cancer Medical Device

Interventions

BRA CONNECT deviceDEVICE

skin thermal analysis for the detection of breast abnormalities

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

ICANS (Institut de Cancérologie de Strasbourg)

Strasbourg, France

NOT_YET_RECRUITING

Hôpital Nord Franche-Comté

Trévenans, France

RECRUITING

Outcomes

Primary Outcomes

Assess the ability of the device to detect breast abnormalities or not, in healthy women or women with a non-specific invasive carcinoma diagnosed.

Sensitivity and specificity of the device to detect a breast abnormality

Time frame: 20 minutes of recording

Central Contacts

Elodie Bouvier

CONTACT

384983570 elodie.bouvier@hnfc.fr

Data from ClinicalTrials.gov

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