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

Completed · Not applicable

Conditions studied: Breast Screening

In brief

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.

Key facts

Study ID

NCT04761055

Run by

Memorial Sloan Kettering Cancer Center

People needed

300

Starts

2021-01-29

Expected to finish

2025-08-19

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Male patients
• Patients under 18 years of age, unable to consent
• Pregnant patients
• Lactating patients
• Non-intact skin

Where it is running

• 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

Full record on ClinicalTrials.gov

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