Clinical Utility Study of a Low-Cost Hand-Held Breast Scanner

Study Overview
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Brief Summary
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The primary purpose of this study is to measure the clinical utility (accuracy) of the hand-held breast scanner (iBE) for the detection of breast lesions or lumps. The iBE results will be compared to the results of a current mammogram and/or ultrasound. The duration of study participation is approximately 30 minutes one day.

Detailed Description
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The FDA approved class II device in this clinical trial is a low-cost hand-held breast scanner (intelligent Breast Exam, iBE). This device is to be used a pre-screening tool for mammograms or ultrasounds. Determination of the accuracy of iBE for the detection of clinically relevant breast lesions will be performed by means of a prospective study. The iBE evaluation will be performed by a trained licensed practical nurse or ultrasound technologist who is blinded to the outcome of the radiology studies at the time the iBE is performed. The iBE training will be done by the leading iBE user in the United States. The iBE evaluation will be done prior to the patient's original scheduled imaging visit. After the completion of the imaging visit the radiologist will evaluate the mammogram and/or ultrasound images along with the iBE report.

Official Title
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Clinical Utility Study of a Low-Cost Hand-Held Breast Scanner

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: intelligent Breast Exam, iBE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age and older Women and men with symptomatic breast lump (either by palpation or imaging) OR Asymptomatic women presenting to the imaging center for a screening mammogram Signed Informed Consent Exclusion Criteria: Patients under 18 years of age Patients who previously participated in this study and are returning to the Women's Imaging Center for follow-up diagnostic tests

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: intelligent Breast Exam, iBE<br>Single Arm: Additional breast exam by a FDA approved hand-held intelligent breast exam device and a clinical breast exam during their scheduled breast screening appointment. No return visit required for participation. | Device: intelligent Breast Exam, iBE<br>* A bilateral iBE exam will be performed on the entire breast in addition to a clinical breast exam administered by a trained individual. If the patient is selected to participate in the inter-rater reliability portion of the study, the subject will undergo both the iBE and the clinical breast exams twice sequentially performed by two different separately trained individuals during the same visit.<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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Position of the Breast Lesion as Measured by iBE and Mammography | agreement of the position of the lesion, defined by time coordinate measured by iBE and mammography or ultrasound that fall within a 3 hour time quadrants on a clock of each other. | approximately one month after imaging | 
| Size Detection of the Breast Lesions Identified by iBE | The size detected of the breast lesion (cm) by mammogram or ultrasound | approximately one month after imaging | 
| Inter-rate Reliability of the iBE and the CBE Number of Lesions Detected | comparing the number of breast lesions detected two independent healthcare professionals consecutive evaluations of the same patient with the iBE device and clinical breast exam | through study completion an average of 18 months | 
| Inter-rate Reliability of the iBE and the CBE Position of Lesions Detected | comparing the position(s) results of two independent healthcare professionals consecutive evaluations of the same patient with the iBE device and clinical breast exam | through study completion an average of 18 months | 
| Post-stratification of the Analysis of the Reliability by Breast Imaging Reporting and Data System Level | breakdown of the iBE clinically relevant findings and negative findings by the BIRAD levels determination from the gold standard final results | through study completion an average of 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast lump, breast exam, breast cancer screening, breast lump detection