Study of iBreast, a Handheld Device to Detect Breast Abnormalities During Screening Visits for Breast Cancer
Detection of Breast Lesions Utilizing iBreast Exam: A Comparison With Clinical Breast Exam
1 other identifier
interventional
309
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2021
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 29, 2021
CompletedFirst Submitted
Initial submission to the registry
February 16, 2021
CompletedFirst Posted
Study publicly available on registry
February 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 19, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 19, 2025
CompletedAugust 27, 2025
August 1, 2025
4.6 years
February 16, 2021
August 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations (CBE)by Estimating the Sensitivity of the Device Using Imaging Results
comparing the calculated the sensitivities or the percentage of true positive breast lesions (based on imaging results) of the iBE and CBE
approximately one month after imaging scan
Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations by Estimating the Specificity of the Device Using Imaging Results
comparing the calculated the specificities or the percentage of true negative lesions (based on imaging results) of the iBE and CBE
approximately one month after imaging scan
Study Arms (1)
Screening Visits for Breast Cancer
EXPERIMENTALConsenting patients will receive their already scheduled standard CBE and mammogram and in addition will receive a breast exam utilizing the iBreast Exam (iBE).
Interventions
The standard CBE will be performed by a nurse practitioner (NP) who will record any positive CBE finding.
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.
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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- UE LifeSciences Inc.collaborator
- Earlier.orgcollaborator
Study Sites (2)
MSK at Ralph Lauren (All Protocol Activities)
New York, New York, 10035, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Victoria Mango, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2021
First Posted
February 18, 2021
Study Start
January 29, 2021
Primary Completion
August 19, 2025
Study Completion
August 19, 2025
Last Updated
August 27, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.