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Purpose: To establish and validate a regional lymph node (LN) metastasis prediction model of colorectal cancer (CRC) based on 18F-FDG PET/CT and radiomic features using machine-learning methods.Methods: A total of 199 colorectal cancer patients underwent pre-therapy diagnostic 18F-FDG PET/CT scans and CRC radical surgery. The Chang-Gung Image Texture Analysis toolbox (CGITA) was used to extract 70 PET radiomic features reflecting 18F-FDG uptake heterogeneity of tumors. The least absolute shrinkage and selection operator (LASSO) algorithm was used to select radiomic features and develop a radiomic signature score (Rad-score). The training set was used to establish five machine-learning prediction models and the test set was used to test the efficacy of the models. The effectiveness of the models was compared by ROC analysis.Results: The CRC patients were divided into a training set (n = 144) and a test set (n = 55). Two radiomic features were selected to build the Rad-score. Five machine-learning algorithms including logistic regression, support vector machine (SVM), random forest, neural network and eXtreme gradient boosting (XGBoost) were used to established models. Among the five machine-learning models, logistic regression (AUC 0.866, 95% CI 0.808-0.925) and XGBoost (AUC 0.903, 95% CI 0.855-0.951) models performed the best. In the training set, the AUC of these two models were significantly higher than that of the LN metastasis status reported by 18F-FDG PET/CT for differentiating positive and negative regional LN metastases in CRC (all p < 0.05). Good efficacy of the above two models was also achieved in the test set. We created a nomogram based on the logistic regression model that visualized the results and provided an easy-to-use method for predicting regional LN metastasis in patients with CRC.Conclusion: In this study, five machine-learning models for preoperative prediction of regional LN metastasis of CRC based on 18F-FDG PET/CT and PET-based radiomic features were successfully developed and validated. Among them, the logistic regression and XGBoost models performed the best, with higher efficacy than 18F-FDG PET/CT in both the training and test sets. [ABSTRACT FROM AUTHOR]