Automated, Low-Cost Palpable Breast Lump Triage For Economically-Developing Countries

Background: According to GLOBOCAN, 1.7 million women were diagnosed with breast cancer and 445,000 died from the disease in 2012. Breast cancer is the most common cause of cancer death among women worldwide and the numbers are disproportionately high for women in developing countries. Furthermore, breast cancer is more common in young women (age 44 and under) in these countries than in industrialized countries. Shifts in lifestyle typical of industrialized societies are thought to be causing a rise in breast cancer incidence while technical advances in detection, diagnosis, and treatment are not reaching these areas of the world. In developing countries, breast cancer commonly presents in women as a palpable mass and a low-cost solution for breast cancer triage would be beneficial. Ultrasound has been shown to perform very well on palpable masses, is non-ionizing, and affordable, portable systems are available. In the ACRIN 6666 clinical study of asymptomatic women, adding screening ultrasound to mammography significantly increased breast cancer detection in women with elevated cancer risk and dense breasts, and more invasive cancers were seen by ultrasound alone than by mammography alone. Method: We propose a novel computer-aided diagnosis (CADx) tool for breast cancer triage using a low-cost ultrasound imaging device that will automatically distinguish among (1) suspicious lesions to be sent for biopsy, (2) benign findings that need no additional follow-up and (3) probably benign findings with recommended 6-month follow-up. A validation study at USC Norris Cancer Center and Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center was performed in order to assess the performance of the triage software compared to the standard-of-care and biopsy-confirmed cancers and false positives. The Study machine was the GE Logiq e ultrasound imaging device, which is FDA-approved for small body parts. Lesions that were assessed as BI-RADS 2 by radiologists were determined to be benign while any lesion assessed as BI-RADS 4a or higher was sent for biopsy. This study cohort included women 61 years of age or younger with a palpable mass. The triage software was compared to the performance by radiologists using conventional standard-of-care for palpable masses. Results: The original milestone for this study was to achieve a sensitivity of 85% while reducing the number of benign lesions going to biopsy by 40%. The validation study showed an actual sensitivity of 100% while reducing the number of benign lesions going to biopsy by 69%. To date, the images collected during the validation study include 152 lesions in total, 22 biopsy-proven cancers and 130 benign lesions; 63 benign lesions were categorized as BI-RADS 4a or higher by a radiologist and sent for biopsy. Conclusions: The validation study showed that adding automated breast cancer triage software to a low-cost portable ultrasound imaging device is a realistic approach for regions of the world with limited access to highly trained radiologists and diagnostic equipment. Funding: NIH Grant #UH2EB019889. Citation Format: Love SM, Berg WA, Podilchuk C, Hovanessian-Larsen LJ, Dauphine C, Jairaj A, Barinov L, Hulbert W, Cen S, Eshraghi L, Mammone R. Automated, low-cost palpable breast lump triage for economically-developing countries [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr PD3-01.