iBreastExam Device for Breast Cancer Screening

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byVictoria Mango, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Victoria Mango, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for women over 18 who can give consent and are visiting clinics for a routine breast cancer screening, which includes a mammogram and clinical breast exam. It's open to both asymptomatic and symptomatic patients. However, it excludes pregnant or lactating women, men, those under 18 or unable to consent, and anyone with non-intact skin.

Inclusion Criteria

I am over 18 and can make my own medical decisions.

RLC patients presenting to RLC or BAIC for mammogram and CBE

I have symptoms or no symptoms of my condition.

See 1 more

Exclusion Criteria

You are pregnant.

You are currently breastfeeding.

I am under 18 and cannot give consent on my own.

See 2 more

Treatment Details

Interventions

iBreastExam device (Device)

Trial OverviewThe study is evaluating the iBreastExam device against standard breast cancer screenings like mammograms. The device uses electronic palpation to create a color map of the breast that highlights potential abnormalities needing further medical evaluation.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Screening Visits for Breast CancerExperimental Treatment3 Interventions

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