BACKGROUND: This study develops a deep learning-based automated lesion segmentation model for whole-body 3D18F-fluorodeoxyglucose (FDG)-Position emission tomography (PET) with computed tomography (CT) images agnostic to disease location and site. METHOD: A publicly available lesion-annotated dataset of 1014 whole-body FDG-PET/CT images was used to train, validate, and test (70:10:20) eight configurations with 3D U-Net as the backbone architecture. The best-performing model on the test set was further evaluated on 3 different unseen cohorts consisting of osteosarcoma or neuroblastoma (OS cohort) (n = 13), pediatric solid tumors (ST cohort) (n = 14), and adult Pheochromocytoma/Paraganglioma (PHEO cohort) (n = 40). Both lesion-level and patient-level statistical analyses were conducted to validate the performance of the model on different cohorts. RESULTS: The best performing 3D full resolution nnUNet model achieved a lesion-level sensitivity and DISC of 71.70 % and 0.40 for the test set, 97.83 % and 0.73 for ST, 40.15 % and 0.36 for OS, and 78.37 % and 0.50 for the PHEO cohort. For the test set and PHEO cohort, the model has missed small volume and lower uptake lesions (p < 0.01), whereas no statistically significant differences (p > 0.05) were found in the false positive (FP) and false negative lesions volume and uptake for the OS and ST cohort. The predicted total lesion glycolysis is slightly higher than the ground truth because of FP calls, which experts can easily check and reject. CONCLUSION: The developed deep learning-based automated lesion segmentation AI model which utilizes 3D_FullRes configuration of the nnUNet framework showed promising and reliable performance for the whole-body FDG-PET/CT images.

Artificial Intelligence Resource National Cancer Institute National Institute of Health Bethesda MD 20814 USA

Artificial Intelligence Resource National Cancer Institute National Institute of Health Bethesda MD 20814 USA; Molecular Imaging Branch National Cancer Institute National Institute of Health Bethesda MD 20892 USA

Molecular Imaging Branch National Cancer Institute National Institute of Health Bethesda MD 20892 USA

Pediatric Oncology Branch National Cancer Institute National Institute of Health Bethesda MD 20892 USA

Section on Medical Neuroendocrinology National Institute of Child Health and Human Development National Institutes of Health Bethesda 20892 MD USA

Section on Medical Neuroendocrinology National Institute of Child Health and Human Development National Institutes of Health Bethesda 20892 MD USA; AKESO Prague 5 Czech Republic

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