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

Not Applicable

Active, not recruiting

• Conditions: Breast Screening
• Interventions: Other: Clinical Breast exam (CBE); Device: iBreastExam device; Diagnostic Test: mammogram

• Registration Number: NCT04761055
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-29
• Study First Submitted: 2021-02-16
• Study First Submitted QC: 2021-02-16
• Study First Posted: 2021-02-18
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-04
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 310

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Screening Visits for Breast Cancer	Clinical Breast exam (CBE)	Consenting patients will receive their already scheduled standard CBE and mammogram and in addition will receive a breast exam utilizing the iBreast Exam (iBE).
Screening Visits for Breast Cancer	mammogram	Consenting patients will receive their already scheduled standard CBE and mammogram and in addition will receive a breast exam utilizing the iBreast Exam (iBE).
Screening Visits for Breast Cancer	iBreastExam device	Consenting patients will receive their already scheduled standard CBE and mammogram and in addition will receive a breast exam utilizing the iBreast Exam (iBE).

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

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