Accepted for/Published in: JMIR Research Protocols
Date Submitted: Dec 18, 2019
Date Accepted: Aug 13, 2020
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Microwave breast imaging using rotational bistatic impulse-radar for the detection of breast cancer: a prospective diagnostic study
ABSTRACT
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 will evaluate the diagnostic accuracy of the novel microwave breast imaging device.
Methods:
This is a prospective diagnostic study. A total of 120 participants will be recruited before treatment administration and divided into two cohorts: 100 patients diagnosed with breast cancer and 20 participants with benign breast tumors. The detector will be directly placed on each breast in the 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 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 is in progress. We anticipate the preliminary results to be available by Winter 2020.
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. Clinical Trial: Japan registry of clinical trials jRCTs062180005; https://jrct.niph.go.jp/en-latest-detail/jRCTs062180005.
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