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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
516
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.
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
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
Time frame: 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
Time frame: approximately one month after imaging
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.
Time frame: 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
Time frame: 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
Time frame: 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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
Time frame: through study completion an average of 18 months