Smart Bra for Diagnosing Breast Cancer (CBRA)
Primary Purpose
Breast Cancer, Medical Device
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
BRA CONNECT device
Sponsored by
About this trial
This is an interventional screening trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Non-specific invasive carcinoma diagnosed by biopsy
- X-ray images available
- Tumor larger than 2 cm assessed radiologically and/or ultrasound
Exclusion Criteria:
- Contralateral 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
Sites / Locations
- ICANS (Institut de Cancérologie de Strasbourg)
- Hôpital Nord Franche-ComtéRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Patient group
Control group
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05294016
First Posted
March 15, 2022
Last Updated
October 12, 2023
Sponsor
Hopital Nord Franche-Comte
1. Study Identification
Unique Protocol Identification Number
NCT05294016
Brief Title
Smart Bra for Diagnosing Breast Cancer
Acronym
CBRA
Official Title
Smart Bra for Diagnosing Breast Cancer: Pilot Study - CBRA
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 13, 2022 (Actual)
Primary Completion Date
October 28, 2024 (Anticipated)
Study Completion Date
November 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Nord Franche-Comte
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Medical Device
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient group
Arm Type
Other
Arm Title
Control group
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
BRA CONNECT device
Intervention Description
skin thermal analysis for the detection of breast abnormalities
Primary Outcome Measure Information:
Title
Assess the ability of the device to detect breast abnormalities or not, in healthy women or women with a non-specific invasive carcinoma diagnosed.
Description
Sensitivity and specificity of the device to detect a breast abnormality
Time Frame
20 minutes of recording
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elodie Bouvier
Phone
384983570
Ext
+33
Email
elodie.bouvier@hnfc.fr
Facility Information:
Facility Name
ICANS (Institut de Cancérologie de Strasbourg)
City
Strasbourg
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carole MATHELIN, Pr
Facility Name
Hôpital Nord Franche-Comté
City
Trevenans
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine GAY, Pr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Smart Bra for Diagnosing Breast Cancer
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