Study of iBreast, a Handheld Device to Detect Breast Abnormalities During Screening Visits for Breast Cancer

Memorial Sloan Kettering Cancer Center300 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

300

Conditions

Breast Screening

Interventions

Clinical Breast exam (CBE)

iBreastExam deviceDEVICE

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.

mammogramDIAGNOSTIC_TEST

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

MSK at Ralph Lauren (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

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

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 scan