Detection of Breast Lesions Utilizing iBreast Exam: A Comparison With Clinical Breast Exam
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 309
- Locations
- 2
- Primary Endpoint
- Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations (CBE)by Estimating the Sensitivity of the Device Using Imaging Results
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations (CBE)by Estimating the Sensitivity of the Device Using Imaging Results
Time Frame: 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
Time Frame: approximately one month after imaging scan
comparing the calculated the specificities or the percentage of true negative lesions (based on imaging results) of the iBE and CBE
Secondary Outcomes
No secondary outcomes reported