Abstract P6-02-17: Hand-held impulse-radar detector for breast cancer: development and a pilot study

Abstract

Abstract Background: Microwave breast imaging, which using the difference in the dielectric properties between breast cancer and normal breast tissue, is a painless and non-radiation method. We have created a novel hand-held prototype of breast cancer detector using impulse-radar based imaging system, and conducted a pilot clinical study. Methods: The detector consists of complementary metal-oxide-semiconductor (CMOS) integrated circuits covering the ultrawideband width from 3.1 to 10.6 GHz, which enable the generation and transmission of Gaussian monocycle pulse (GMP) trains and single port eight throw switching matrices (SP8T-SW) for controlling a 4×4 cross-shaped dome antenna array. The size of the detector was 19.1 × 17.7 × 18.8 cm. After evaluation using a breast tumor phantom and the resected breast specimens obtained through mastectomy, we recruited 5 patients with histologically confirmed breast cancers in the clinical study. The detector was placed on the breast with the patient in a supine position. The primary endpoint was a detection rate of breast cancers, and the secondary endpoints were positional accuracy and adverse event. This study was registered with the UMIN Clinical Trials Registry (UMIN000026181). Results: The three-dimensional positions of the tumors in the imaging results using a phantom and resected specimens are consistent with the results of histopathology analysis. In the clinical study, all 5 targeted breast cancers were detected and were visualized at the sites confirmed by other diagnostic modalities. Among 5 tumors, one was not detected via mammography because of heterogeneously dense breast and another was a microinvasive carcinoma of invasive tumor size 0.5 mm. No study-related adverse events occurred. Conclusions: We succeeded in creating a new device of hand-held impulse-radar detector for breast cancer. The detector has sufficient detective capability, is safe for clinical use, and might detect an early stage breast cancer. In the future, we will proceed with the development to clinical application. Citation Format: Sasada S, Masumoto N, Song H, Goda N, Kajitani K, Emi A, Kadoya T, Arihiro K, Kikkawa T, Okada M. Hand-held impulse-radar detector for breast cancer: development and a pilot study [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P6-02-17.