Breast Screening
Conditions
Keywords
Breast Abnormalities
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.
Interventions
OTHERClinical Breast exam (CBE)
The standard CBE will be performed by a nurse practitioner (NP) who will record any positive CBE finding.
DEVICEiBreastExam device
The iBE is an FDA 510(k) cleared portable device which utilizes an array of dynamic capacitive pressure sensors to perform electronic palpation for breast abnormalities. The iBE exam will be administered by a mammogram technologist, blinded to CBE results.
DIAGNOSTIC_TESTmammogram
All patients will have routine standard mammographic views performed. Patients with positive iBE and/or CBE findings will have additional mammographic and/or ultrasound imaging to determine if a correlating breast lesion is present using the same standard of care algorithm as is used currently for positive CBE findings.
Sponsors
UE LifeSciences Inc.
Earlier.org
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 scan | comparing the calculated the specificities or the percentage of true negative lesions (based on imaging results) of the iBE and CBE |
Countries
United States
Outcome results
None listed