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

Breast Screening Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04761055
• Other study ID #: 19-302
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 29, 2021
• Est. completion date: January 2025

Study information

• Verified date: February 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 310
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Screening

Intervention

Other:
• Clinical Breast exam (CBE)
The standard CBE will be performed by a nurse practitioner (NP) who will record any positive CBE finding.

Device:
• iBreastExam 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.

Diagnostic Test:
• mammogram
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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York
United States	MSK at Ralph Lauren (All Protocol Activities)	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Earlier.org, UE LifeSciences Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center