Study of iBreast, a Handheld Device to Detect Breast Abnormalities During Screening Visits for Breast Cancer
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|ClinicalTrials.gov Identifier: NCT04761055|
Recruitment Status : Active, not recruiting
First Posted : February 18, 2021
Last Update Posted : July 27, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Screening||Other: Clinical Breast exam (CBE) Device: iBreastExam device Diagnostic Test: mammogram||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||310 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Detection of Breast Lesions Utilizing iBreast Exam: A Comparison With Clinical Breast Exam|
|Actual Study Start Date :||January 29, 2021|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||January 2023|
Experimental: Screening Visits for Breast Cancer
Consenting patients will receive their already scheduled standard CBE and mammogram and in addition will receive a breast exam utilizing the iBreast Exam (iBE).
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.
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04761055
|United States, New York|
|MSK at Ralph Lauren (All Protocol Activities)|
|New York, New York, United States, 10035|
|Memorial Sloan Kettering Cancer Center (All Protocol Activities)|
|New York, New York, United States, 10065|
|Principal Investigator:||Victoria Mango, MD||Memorial Sloan Kettering Cancer Center|