NCT04761055

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 309 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Screening

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-01-29
• Primary completion: 2025-08-19
• Completion: 2025-08-19
• First posted: 2021-02-18
• Last updated: 2025-08-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study