An international team of imaging, engineering and cancer experts is developing a novel mobile breast cancer diagnostic kit to improve early diagnosis in low- and middle-income countries — such as Uganda, where systemic delays lead to an advanced stage diagnosis in 70% of breast cancer cases.
A newly awarded five-year, $4 million grant from the U.S. National Cancer Institute supports a partnership between Vanderbilt University Medical Center and the Uganda Cancer Institute (UCI) to optimize, validate, and deploy a portable diagnostic kit for breast cancer that merges innovative point-of-care technologies in ultrasound and cytology. The goal is for the kit to be used at community health centers that provide outpatient care in sparsely populated areas.
Delayed diagnosis is common in underserved communities, especially rural areas that lack hospitals, in the U.S. and around the world. In Uganda, for example, an average 11-month delay results in a high fatality rate. Developing a method of identifying breast cancer in symptomatic women earlier in community care clinics has the potential to improve clinical outcomes, lower mortality, and keep patients close to home, said John Scheel, MD, PhD, MPH, professor of Radiology and vice chair of Global Health in the Department of Radiology and Radiological Sciences at VUMC and co-principal investigator.
“Around the world, women with suspected breast cancer lack reliable, equitable access to standard-of-care methods such as ultrasound, mammography, tissue sampling, and pathology interpretation. Early-stage diagnosis is often not attainable because they live in rural areas. We want to end this disparity by developing a kit that can take a symptomatic woman through her necessary diagnostic tests — from imaging to pathology — within a couple hours,” said Scheel.
Keeping care local
The easily deployable kit will allow non–physician sonographers and cytopathology technologists to be trained to conduct the testing in rural primary care clinics in a single visit.
It combines an FDA-cleared automated artificial intelligence-enabled whole breast ultrasound scanner (ATUSA) and a smartphone-enabled AI-powered pathology device (EpiView-D4) that performs bright-field imaging of basic cytology preparations and incorporates a self-contained immunodiagnostic chip to quantify breast tumor biomarkers.
“A significant proportion of breast cancer patients in resource limited settings present with advanced stage disease (stages 3 and 4) which significantly impacts survival. Development of this kit, which is both accessible and affordable, will significantly improve access to breast cancer diagnosis. Our hope is that we can begin to downstage breast cancer presentation and to improve overall survival from breast cancer,” said co-principal investigator Nixon Niyonzima, MBChB, PhD, MBA, consultant and Research Directorate at the Uganda Cancer Institute.
The kit is an example of how carefully designed projects can improve care and reduce time to diagnosis in ways that cut emissions by finding improvement in the value chain of delivering care, said Scheel, an expert in sustainability in radiology and health care.
“Our emphasis on keeping patients local to their community not only reduces the burden of travel by the patient, but it will also help reduce health care’s carbon footprint by decreasing road travel and improving diagnostic efficiency. It’s vital to use a shared value lens when designing and implementing health care systems so we leave as little footprint as possible while pursuing the best outcome possible for the person,” said Scheel.
Validation at VUMC, then on to Uganda
To validate the efficacy of the kit, radiologists at VUMC will interpret kit results in a group of 500 women who have breast symptoms. The patients will receive testing with both the standard-of-care method as well as the kit, which will then be interpreted by radiologists who have not seen results from the standard-of-care approach.
The diagnostic kit will also be tested and validated at UCI against diagnostic imaging and pathology standard of care using the same protocol used at VUMC to ensure performance is aligned with the standard of care in well-resourced settings.
After validation at VUMC and UCI, researchers will use the kit in a cluster randomized controlled trial of 2,000 women referred for diagnostic evaluation at four community health centers in Uganda and compare the clinical efficacy of the kit with symptomatic women referred for a standard-of-care ultrasound at Ugandan regional hospitals.
The multi-institutional study includes co-investigators from Vanderbilt-Ingram Cancer Center, Fred Hutch Cancer Center, North Carolina State University, and Duke University.
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