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OpenTrials
Completed

NCT Number: NCT04761055

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

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.

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Key information

Conditions

Breast Screening

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

MSK at Ralph Lauren (All Protocol Activities), New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinical Breast exam (CBE)

Other

The standard CBE will be performed by a nurse practitioner (NP) who will record any positive CBE finding.

iBreastExam device

Device

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.

mammogram

Diagnostic 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.

Primary outcomes

  1. Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations (CBE)by Estimating the Sensitivity of the Device Using Imaging Results

    Time frame: 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

  2. Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations by Estimating the Specificity of the Device Using Imaging Results

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Earlier.org
  • UE LifeSciences Inc.

Registry information

Official study title

Detection of Breast Lesions Utilizing iBreast Exam: A Comparison With Clinical Breast Exam

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Feb 18, 2021
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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