Study of iBreast, a Handheld Device to Detect Breast Abnormalities During Screening Visits for Breast Cancer

Study Overview
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Brief Summary
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This study will test the iBreastExam device to find out whether it can detect a mass or lump in the breast as accurately as a routine breast cancer screening examination. The iBreastExam is a handheld device that performs a painless electronic palpation (examination by touch) of the breast. The device is designed to detect breast abnormalities that may require breast imaging and additional clinical examination by a nurse or doctor. The iBreastExam device creates a color map of the breast, with red spots indicating areas that may be abnormal.

Official Title
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Detection of Breast Lesions Utilizing iBreast Exam: A Comparison With Clinical Breast Exam

Conditions
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Breast Screening

Intervention / Treatment
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* Other: Clinical Breast exam (CBE)
* Device: iBreastExam device
* Diagnostic Test: mammogram


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patient Over 18 years of age, able to consent RLC patients presenting to RLC or BAIC for mammogram and CBE Asymptomatic and symptomatic patients will be included Exclusion Criteria: Male patients Patients under 18 years of age, unable to consent Pregnant patients Lactating patients Non-intact skin

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Screening Visits for Breast Cancer<br>Consenting patients will receive their already scheduled standard CBE and mammogram and in addition will receive a breast exam utilizing the iBreast Exam (iBE). | Other: Clinical Breast exam (CBE)<br>* The standard CBE will be performed by a nurse practitioner (NP) who will record any positive CBE finding.<br>Device: iBreastExam device<br>* The iBE is an FDA 510(k) cleared portable device which utilizes an array of dynamic capacitive pressure sensors to perform electronic palpation for breast abnormalities. The iBE exam will be administered by a mammogram technologist, blinded to CBE results.<br>Diagnostic Test: mammogram<br>* All patients will have routine standard mammographic views performed. Patients with positive iBE and/or CBE findings will have additional mammographic and/or ultrasound imaging to determine if a correlating breast lesion is present using the same standard of care algorithm as is used currently for positive CBE findings.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations (CBE)by Estimating the Sensitivity of the Device Using Imaging Results | comparing the calculated the sensitivities or the percentage of true positive breast lesions (based on imaging results) of the iBE and CBE | approximately one month after imaging scan | 
| Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations by Estimating the Specificity of the Device Using Imaging Results | comparing the calculated the specificities or the percentage of true negative lesions (based on imaging results) of the iBE and CBE | approximately one month after imaging scan | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Abnormalities