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

Not Applicable

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
intelligent Breast Exam, iBE	intelligent Breast Exam, iBE	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Inter-rate Reliability of the iBE and the CBE Position of Lesions Detected	through study completion an average of 18 months	comparing the position(s) results of two independent healthcare professionals consecutive evaluations of the same patient with the iBE device and clinical breast exam
Position of the Breast Lesion as Measured by iBE and Mammography	approximately one month after imaging	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.
Size Detection of the Breast Lesions Identified by iBE	approximately one month after imaging	The size detected of the breast lesion (cm) by mammogram or ultrasound
Inter-rate Reliability of the iBE and the CBE Number of Lesions Detected	through study completion an average of 18 months	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
Post-stratification of the Analysis of the Reliability by Breast Imaging Reporting and Data System Level	through study completion an average of 18 months	breakdown of the iBE clinically relevant findings and negative findings by the BIRAD levels determination from the gold standard final results

Locations (1): Pennsylvania Hospital
🇺🇸
Philadelphia, Pennsylvania, United States