Smart Bra for Diagnosing Breast Cancer

Breast Cancer Clinical Trial

— CBRA  

Official title:

Smart Bra for Diagnosing Breast Cancer: Pilot Study - CBRA

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05294016
• Other study ID #: 2021-04
• Status: Recruiting
• Phase: N/A
• Start date: April 13, 2022
• Est. completion date: November 28, 2024

Study information

• Verified date: June 2023
• Source: Hopital Nord Franche-Comte
• Contact: Elodie Bouvier
• Phone: 384983570
• Email: elodie.bouvier[@]hnfc.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: November 28, 2024
• Est. primary completion date: October 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Medical Device

Intervention

Device:
• BRA CONNECT device
skin thermal analysis for the detection of breast abnormalities

Locations

Country	Name	City	State
France	ICANS (Institut de Cancérologie de Strasbourg)	Strasbourg
France	Hôpital Nord Franche-Comté	Trevenans

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Nord Franche-Comte

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	20 minutes of recording