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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Active, not recruiting

Conditions: Breast Screening

Treatments: Device: iBreastExam device; Diagnostic Test: mammogram; Other: Clinical Breast exam (CBE)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04761055

19-302

Details and patient eligibility

About

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.

Enrollment: 310 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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310 participants in 1 patient group

Screening Visits for Breast Cancer

Experimental group

Description:

Consenting patients will receive their already scheduled standard CBE and mammogram and in addition will receive a breast exam utilizing the iBreast Exam (iBE).

Treatment:

Other: Clinical Breast exam (CBE)

Diagnostic Test: mammogram

Device: iBreastExam device