Fast-Track Development and Multi-Institutional Clinical Validation of an Artificial Intelligence Algorithm for Detection of Lymph Node Metastasis in Colorectal Cancer.

Journal: Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc
Published Date: Apr 16, 2024

Abstract

Lymph node metastasis (LNM) detection can be automated using artificial intelligence (AI)-based diagnostic tools. Only limited studies have addressed this task for colorectal cancer (CRC). This study aimed to develop of a clinical-grade digital pathology tool for LNM detection in 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 5 pathology departments digitized by 4 different scanning systems. A high-quality, large training data set 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 to 1.000, 0.997 to 1.000, and 0.913 to 0.990, correspondingly. Only 5 of 14,460 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, multiscanner cohort of cases to date, showing very high precision for LNM detection in CRC. We are releasing a part of the test data sets to facilitate academic research.

Authors

  • Avri Giammanco
    Institute of Pathology, University Hospital Cologne, Cologne, Germany.
  • Andrey Bychkov
    Department of Pathology, Nagasaki University Graduate School of Biomedical Sciences, Sakamoto, Nagasaki, Japan; Department of Pathology, Kameda Medical Center, Kamogawa, Chiba, Japan.
  • Simon Schallenberg
    From the Department of Radiology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Virchow Klinikum, Augustenburgerplatz 1, 13353 Berlin, Germany (C.A.H., G.L.B., N.L.B., A.H., L.J.S., K.F., F.D., M.R., A.D.J.B., B.H., M.H., S.H., T.P.); Berlin Institute of Health (BIH), Berlin, Germany (C.A.H., N.L.B., L.J.S., T.P.); Faculty VI-Informatics and Media, Berliner Hochschule für Technik (BHT), Einstein Center Digital Future, Berlin, Germany (G.L.B., F.B.); Bayer AG, Medical Affairs and Pharmacovigilance, Integrated Evidence Generation & Business Innovation, Berlin, Germany (A.H.); Institute of Pathology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Berlin, Germany (S.S.); and Department of Urology, Otto-von-Guericke-University Magdeburg, Germany and PROURO, Berlin, Germany (H.C.).
  • Tsvetan Tsvetkov
    Institute of Pathology, University Hospital Cologne, Cologne, Germany.
  • Junya Fukuoka
    Department of Pathology, Nagasaki University Graduate School of Biomedical Sciences, Sakamoto, Nagasaki, Japan; Department of Pathology, Kameda Medical Center, Kamogawa, Chiba, Japan. Electronic address: fukuokaj@nagasaki-u.ac.jp.
  • Alexey Pryalukhin
    Institute of Pathology, Landesklinikum Wiener Neustadt, Wiener Neustadt, Austria.
  • Fabian Mairinger
    Institute of Pathology, University Hospital Essen, Essen, Germany.
  • Alexander Seper
    Danube Private University, Medical Faculty, Krems-Stein, Austria.
  • Wolfgang Hulla
    Institute of Pathology, Landesklinikum Wiener Neustadt, Wiener Neustadt, Austria.
  • Sebastian Klein
    Else-Kröner-Forschungskolleg, Clonal Evolution in Cancer, University Hospital Cologne, Cologne, Germany. Sebastian.Klein@uk-koeln.de.
  • Alexander Quaas
    Institute of Pathology, University Hospital Cologne, Cologne, Germany.
  • Reinhard Büttner
    Institute of Pathology, University Hospital Cologne, Cologne, Germany.
  • Yuri Tolkach
    Institute of Pathology, University Hospital Cologne, Cologne, Germany. yuri.tolkach@gmail.com.

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