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Development and deployment of a histopathology-based deep learning algorithm for patient prescreening in a clinical trial
oleh: Albert Juan Ramon, Chaitanya Parmar, Oscar M. Carrasco-Zevallos, Carlos Csiszer, Stephen S. F. Yip, Patricia Raciti, Nicole L. Stone, Spyros Triantos, Michelle M. Quiroz, Patrick Crowley, Ashita S. Batavia, Joel Greshock, Tommaso Mansi, Kristopher A. Standish
Format: | Article |
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Diterbitkan: | Nature Portfolio 2024-06-01 |
Deskripsi
Abstract Accurate identification of genetic alterations in tumors, such as Fibroblast Growth Factor Receptor, is crucial for treating with targeted therapies; however, molecular testing can delay patient care due to the time and tissue required. Successful development, validation, and deployment of an AI-based, biomarker-detection algorithm could reduce screening cost and accelerate patient recruitment. Here, we develop a deep-learning algorithm using >3000 H&E-stained whole slide images from patients with advanced urothelial cancers, optimized for high sensitivity to avoid ruling out trial-eligible patients. The algorithm is validated on a dataset of 350 patients, achieving an area under the curve of 0.75, specificity of 31.8% at 88.7% sensitivity, and projected 28.7% reduction in molecular testing. We successfully deploy the system in a non-interventional study comprising 89 global study clinical sites and demonstrate its potential to prioritize/deprioritize molecular testing resources and provide substantial cost savings in the drug development and clinical settings.