Microwave Breast Imaging Using Rotational Bistatic Impulse Radar for the Detection of Breast Cancer: Protocol for a Prospective Diagnostic Study

BACKGROUND: Mammography is the standard examination for breast cancer screening; however, it is associated with pain and exposure to ionizing radiation. Microwave breast imaging is a less invasive method for breast cancer surveillance. A bistatic impulse radar–based breast cancer detector has recently been developed. OBJECTIVE: This study aims to present a protocol for evaluating the diagnostic accuracy of the novel microwave breast imaging device. METHODS: This is a prospective diagnostic study. A total of 120 participants were recruited before treatment administration and divided into 2 cohorts: 100 patients diagnosed with breast cancer and 20 participants with benign breast tumors. The detector will be directly placed on each breast, while the participant is in supine position, without a coupling medium. Confocal images will be created based on the analyzed data, and the presence of breast tumors will be assessed. The primary endpoint will be the diagnostic accuracy, sensitivity, and specificity of the detector for breast cancer and benign tumors. The secondary endpoint will be the safety and detectability of each molecular subtype of breast cancer. For an exploratory endpoint, the influence of breast density and tumor size on tumor detection will be investigated. RESULTS: Recruitment began in November 2018 and was completed by March 2020. We anticipate the preliminary results to be available by summer 2021. CONCLUSIONS: This study will provide insights on the diagnostic accuracy of microwave breast imaging using a rotational bistatic impulse radar. The collected data will improve the diagnostic algorithm of microwave imaging and lead to enhanced device performance. TRIAL REGISTRATION: Japan Registry of Clinical Trials jRCTs062180005; https://jrct.niph.go.jp/en-latest-detail/jRCTs062180005 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/17524