Breast cancer is one of the greatest global health concerns for women, with rising incidence rates and mortality projections, while affordability and access to mammography screening and diagnosis, especially in low- and middle-income countries, remain a challenge. This retrospective clinical validation study evaluated a breast cancer pre-screening solution (BCPS) based on a commercially available smartphone with a thermal imaging sensor powered by artificial intelligence. The purpose was to measure the performance of the BCPS tool compared to mammography, the gold standard for first-pass examination in breast cancer screening.
https://www.xiahepublishing.com/2835-3315/CSP-2023-00034S
Methods
The evaluation was conducted in the Erebouni Medical Center Breast Unit in Armenia over a period of six months. We tested a cohort of 478 women of whom 45 were finally diagnosed with breast cancer after biopsy. Participants were first screened with the BCPS before undergoing the standard breast screening pathway. After studying the mammography results, if malignancy was discovered, a biopsy was performed and taken as the ground truth when comparing with BCPS artificial intelligence results.
Results
When combined with patient-reported or clinical symptoms, the BCPS tool achieved a sensitivity of 89% and a specificity of 83% compared to mammography. When clinical or patient-reported symptoms were not taken into account, sensitivity was considerably lower (60%), while specificity was higher (88.2%).
Conclusions
This study provides evidence that the BCPS tool using a smartphone-based thermal imaging sensor and AI in combination helps to detect breast cancers earlier, especially in settings where mammography as a standard of care is not available or accessible as a first-pass screening or diagnostic tool. This is particularly relevant for low- and middle-income countries. BCPS can also be used in high-income countries to pre-screen women outside of the recommended screening age range who seek primary care as a first step as well as to provide a pre-screening option for women who currently do not wish to undergo mammography for various reasons such as fear, psychological concerns, financial constraints, limited availability, lack of awareness, and cultural factors and are thus being missed by healthcare. Further studies are needed to validate these findings. In the future, more studies should be performed for different use cases such as the investigation of pathological lymph nodes. Also, it might be useful to compare the device to other modalities used in breast cancer screening and detection such as POCT (Point-of-Care Testing), MRI, and CEM (contrast-enhanced mammography).
Full text
https://www.xiahepublishing.com/2835-3315/CSP-2023-00034S
The study was recently published in the Cancer Screening and Prevention.
Cancer Screening and Prevention (CSP) publishes high-quality research and review articles related to cancer screening and prevention. It aims to provide a platform for studies that develop innovative and creative strategies and precise models for screening, early detection, and prevention of various cancers. Studies on the integration of precision cancer prevention multiomics where cancer screening, early detection and prevention regimens can precisely reflect the risk of cancer from dissected genomic and environmental parameters are particularly welcome.