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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.

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.

intelligent Breast Exam, iBE

Ari D Brooks, MD

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.

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.

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

comparing the calculated the sensitivities or the percentage of true positive breast lesions (based on imaging results) of the iBE and CBE

comparing the calculated the specificities or the percentage of true negative lesions (based on imaging results) of the iBE and CBE

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.

The size detected of the breast lesion (cm) by mammogram or ultrasound

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

comparing the position(s) results of two independent healthcare professionals consecutive evaluations of the same patient with the iBE device and clinical breast exam

breakdown of the iBE clinically relevant findings and negative findings by the BIRAD levels determination from the gold standard final results

UE LifeSciences Inc.

University of Pennsylvania

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.

intelligent Breast Exam, iBE: 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.

Intelligent Breast Exam, iBE

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Patients analyzed were those who completed all exams required by the protocol.

* difficulty recruiting patients with positive mammograms as this was unknown at time of enrollment
* difficulty recruiting patients for dual study for the inter-reliability study due to the increase in their scheduled visit time.

Dr. Ari D Brooks

Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations (CBE)by Estimating the Sensitivity of the Device Using Imaging Results

Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations by Estimating the Specificity of the Device Using Imaging Results

Number of subjects who had a lesion identified by iBE and mammogram, ultrasound, or MRI.

Position of the Breast Lesion as Measured by iBE and Mammography

The size was not measured by iBE. Only 4 of the 7 lesions were detected by iBE and size data was not available to analyze.

Size Detection of the Breast Lesions Identified by iBE

Difficulty enrolling patients for this outcome as a result of the participants undergoing the iBE and CBE twice by two different healthcare professionals. Subjects declined to continue after first healthcare professional exams was complete. Comparison data between healthcare professionals was not available to analyze.

Inter-rate Reliability of the iBE and the CBE Number of Lesions Detected

Inter-rate Reliability of the iBE and the CBE Position of Lesions Detected

The specificity of iBE relevant findings (BIRADs 0, 3-5) vs benign findings (BIRADS 1, 2) from the results of mammography

Spots Global Cancer Trial Database for breast lump detection