Fast-track development and multi-institutional clinical validation of an artificial intelligence algorithm for detection of lymph node metastasis in colorectal cancer

Lymph node metastasis (LNM) detection can be automated using artificial intelligence-based diagnostic tools. Only limited studies have addressed this task for colorectal cancer. The aim of this study was to develop of a clinical-grade digital pathology tool for LNM detection in colorectal cancer (CRC) using the original fast-track framework.The training cohort included 432 slides from one department. A segmentation algorithm detecting 8 relevant tissue classes was trained. The test cohorts consisted of materials from five pathology departments digitized by four different scanning systems.A high-quality, large training dataset was generated within 7 days, and a minimal amount of annotation work using fast-track principles. The AI tool showed very high accuracy for LNM detection in all cohorts, with sensitivity, negative predictive value, and specificity ranges of 0.980-1.000, 0.997-1.000, and 0.913-0.990, correspondingly. Only 5 of 14460 analyzed test slides with tumor cells over all cohorts were classified as false negative (3/5 representing clusters of tumor cells in lymphatic vessels).A clinical-grade tool was trained in a short time using fast-track development principles and validated using the largest international, multi-institutional, multi-scanner cohort of cases to date, showing very high precision for LNM detection in CRC. We are releasing a part of the test datasets to facilitate academic research.