This clinical trial studies whether the iBreastExam device is as effective in detecting breast abnormalities (a mass or lump) compared with standard breast cancer screening methods (clinical breast examination and mammogram). 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. Information from this study may help researchers improve the process of screening for breast cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT04761055.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To determine the sensitivity and specificity of the piezoelectric breast palpation (iBreast Exam [iBE]) for detecting breast lesions using breast imaging, mammography and ultrasound (when indicated) and clinical follow up (when indicated) as a reference standard.
SECONDARY OBJECTIVES:
I. To assess imaging findings of lesions detected and missed on iBE (i.e., masses, calcifications, asymmetries, focal asymmetries, distortion).
II. To examine pathology results of lesions detected and missed on iBE (i.e., invasive cancer, in situ cancer, high risk lesions, and benign lesions).
III. Survey technologists conducting the iBE regarding their experiences utilizing the device.
OUTLINE:
Patients undergo standard of care clinical breast exam (CBE) and mammogram and then undergo iBE over 10 minutes. Patients with a positive iBE finding receive an additional mammogram. If there is no correlating lesion, patients undergo an additional CBE and iBE at 1 month. If the iBE is negative and CBE remain negative patients undergo annual mammogram. If the CBE is positive, patients are referred to a breast surgeon. If the CBE is negative but iBE is positive patients undergo iBE and CBE at 6 months.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorVictoria Lee Mango
