Evaluation of the Diagnostic Performance of a Bra Prototype to Detect Breast Cancer
NCT ID: NCT05574816
Last Updated: 2024-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2023-03-30
2024-02-01
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Patient without breast lump
No breast lump identified during mammography (ACR 1 et 2 Birads classification)
Phi-Bra prototype measurements
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.
Patient with breast lump
Suspicious breast lump identified during mammography (ACR 4b, c ou ACR 5 Birads classification)
Phi-Bra prototype measurements
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.
Interventions
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Phi-Bra prototype measurements
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.
Eligibility Criteria
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Inclusion Criteria
* 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 lump classified as ACR 3 ou ACR 4a during the mammography
18 Years
75 Years
FEMALE
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Marion CORTET, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
Locations
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Service de Gynecologie-Obstetrique, Hopital de la Croix Rousse
Lyon, , France
Service de Radiologie, Hôpital de la Croix-Rousse
Lyon, , France
Countries
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Other Identifiers
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69HCL21_1085
Identifier Type: -
Identifier Source: org_study_id
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