Evaluation of the Diagnostic Performance of a Bra Prototype to Detect Breast Cancer (Phi-Bra)
Primary Purpose
Breast Neoplasm Female
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Phi-Bra prototype measurements
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Neoplasm Female focused on measuring Breast cancer detection, impedance
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Breast cancer background (surgery or radiotherapy)
- Breast lump classified as ACR 3 ou ACR 4a during the mammography
Sites / Locations
- Service de Gynecologie-Obstetrique, Hopital de la Croix Rousse
- Service de Radiologie, Hôpital de la Croix-RousseRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Patient without breast lump
Patient with breast lump
Arm Description
No breast lump identified during mammography (ACR 1 et 2 Birads classification)
Suspicious breast lump identified during mammography (ACR 4b, c ou ACR 5 Birads classification)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
impedance optimal threshold
Determination of the impedance optimal threshold to detect breast lump in term of specificity and sensitivity (in Ohms)
Correlation between lump volume and device impedance
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05574816
Brief Title
Evaluation of the Diagnostic Performance of a Bra Prototype to Detect Breast Cancer
Acronym
Phi-Bra
Official Title
Evaluation of the Diagnostic Performance of a Bra Prototype to Detect Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2023 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm Female
Keywords
Breast cancer detection, impedance
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient without breast lump
Arm Type
Active Comparator
Arm Description
No breast lump identified during mammography (ACR 1 et 2 Birads classification)
Arm Title
Patient with breast lump
Arm Type
Experimental
Arm Description
Suspicious breast lump identified during mammography (ACR 4b, c ou ACR 5 Birads classification)
Intervention Type
Device
Intervention Name(s)
Phi-Bra prototype measurements
Intervention Description
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.
Primary Outcome Measure Information:
Title
Aria Under Receiver Operating Characteristic (ROC) Curve
Description
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.
Time Frame
The day of inclusion
Secondary Outcome Measure Information:
Title
impedance optimal threshold
Description
Determination of the impedance optimal threshold to detect breast lump in term of specificity and sensitivity (in Ohms)
Time Frame
The day of inclusion
Title
Correlation between lump volume and device impedance
Time Frame
The day of inclusion
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Breast cancer background (surgery or radiotherapy)
Breast lump classified as ACR 3 ou ACR 4a during the mammography
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marion CORTET, MD, PhD
Phone
+33 4 27 85 40 78
Email
marion.cortet@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marion CORTET, MD, PhD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Gynecologie-Obstetrique, Hopital de la Croix Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marion CORTET, MD, PhD
First Name & Middle Initial & Last Name & Degree
Marion CORTET, MD, PhD
Facility Name
Service de Radiologie, Hôpital de la Croix-Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorothée TACONET, TACONET
Phone
+33 4 26 10 91 85
Email
dorothee.taconet@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Dorothée TACONET, TACONET
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Diagnostic Performance of a Bra Prototype to Detect Breast Cancer
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