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Self-Reading Portable Ultrasound

Low Cost Automated Ultrasound for Breast Cancer Detection and Diagnosis

Breast cancer is the leading cause of death and disability among women, especially young women, in low- and middle-income countries (LMIC). Survival rates in developing countries are less than half that of the United States, mainly due to a lack of resources for diagnosis and treatment. In August 2014, the National Institutes of Health (NIH) awarded a nearly $1 million grant to Dr. Susan Love Research Foundation to develop technology aimed at addressing this serious women’s health issue.

The two-year UH2 Phase I exploratory cooperative agreement will support work on a portable self-reading ultrasound that can be used by local health aides to triage palpable breast lumps. This will allow them to distinguish between benign tumors and tumors that might be malignant and should be biopsied.

The goal for the UH2 grant period is to develop a low-cost, self-reading ultrasound device by using imaging enhancing algorithms and computer-aided detection and diagnosis (CAD), to distinguish between malignant palpable lumps and clearly benign lumps, such as cysts, fibroadenomas, and fibrocystic change. The easy-to-use device will not require highly trained professional staff for operation. Thus, the device will be accessible to a broader range of LMIC health care facilities, and enable the already-stressed health care systems to focus resources on the women most likely to benefit from their efforts.

Proven pattern recognition technology, novel algorithms for ultrasound image enhancement, and computer-aided detection and diagnosis will be combined with real-time information generated by the live ultrasound scans to determine the probability of malignancy. A clinical validation trial will be performed at county hospitals in Southern California in 2015-2016 to determine the sensitivity and specificity of the ultrasound device. The NIH will then assess the feasibility for transitioning the project to a UH3 Phase II grant, which would include a clinical trial in Jalisco, Mexico, to validate effectiveness, and acceptability of the device in a developing country.

The device development and clinical validations will be performed in close collaboration between breast cancer expert and surgeon Susan M. Love, MD, MBA (Dr. Susan Love Research Foundation), and breast imaging radiologist and clinical trial expert Wendie Berg, MD, PhD, FACR (University of Pittsburgh School of Medicine, Magee-Womens Hospital of UPMC), medical software product development and commercialization expert Christine Podilchuk, PhD (ClearView Diagnostics), and technology and commercialization expert Richard Mammone, PhD, MEEE, BEEE (ClearView Diagnostics/Rutgers, The State University of New Jersey). Mammone, who is a professor of electrical and computer engineering and a professor at the Rutgers Business School, invented the scanner technology and founded ClearView Diagnostics.