To determine whether artificial intelligence (AI) processed PET/CT images of reduced by one-third of 18-F-FDG activity compared to the standard injected dose, were non-inferior to native scans and if so to assess the potential impact of commercialization. SubtlePET™ AI was introduced in a PET/CT center in Italy. Eligible patients referred for 18F-FDG PET/CT were prospectively enrolled. Administered 18F-FDG was reduced to two-thirds of standard dose. Patients underwent one low-dose CT and two sequential PET scans; “PET-processed” with reduced dose and standard acquisition time, and “PET-native” with an elapsed time to simulate standard acquisition time and dose. PET-processed images were reconstructed using SubtlePET™. PET-native images were defined as the standard of reference. The datasets were anonymized and independently evaluated in random order by four blinded readers. The evaluation included subjective image quality (IQ) assessment, lesion detectability, and assessment of business benefits. From February to April 2020, 61 patients were prospectively enrolled. Subjective IQ was not significantly different between datasets (4.62±0.23, p=0.237) for all scanner models, with “almost perfect” inter-reader agreement. There was no significant difference between datasets in lesions’ detectability, target lesion mean SUVmax value, and liver mean SUVmean value (182.75/181.75 [SD:0.71], 9.8/11.4 [SD:1.13], 2.1/1.9 [SD:0.14] respectively). No false-positive lesions were reported in PET-processed examinations. Agreed SubtlePET™ price per examination was 15-20% of FDG savings. This is the first real-world study to demonstrate the non-inferiority of AI processed 18F-FDG PET/CT examinations obtained with 66% standard dose and a methodology to define the AI solution price.

中文翻译：

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用于减少剂量 18F-FDG PET 检查的人工智能：通过标准化框架和业务案例评估进行实际部署


确定人工智能 (AI) 处理的 PET/CT 图像与标准注射剂量相比，18-F-FDG 活性减少三分之一，是否不劣于原生扫描，如果是，则评估商业化的潜在影响。 SubtlePET™ AI 被引入意大利的 PET/CT 中心。前瞻性纳入转诊接受 18F-FDG PET/CT 的合格患者。所施用的 18F-FDG 减少至标准剂量的三分之二。患者接受了一次低剂量 CT 扫描和两次连续 PET 扫描； “PET-processed”具有减少的剂量和标准采集时间，“PET-native”具有模拟标准采集时间和剂量的经过时间。使用 SubtlePET™ 重建 PET 处理的图像。 PET 原始图像被定义为参考标准。这些数据集是匿名的，并由四位盲人读者以随机顺序独立评估。评估包括主观图像质量 (IQ) 评估、病变可检测性和商业效益评估。从2020年2月至2020年4月，前瞻性入组了61名患者。所有扫描仪型号的数据集之间的主观智商没有显着差异（4.62±0.23，p=0.237），读者间的一致性“几乎完美”。病灶可检测性、目标病灶平均 SUVmax 值和肝脏平均 SUVmean 值之间没有显着差异（182.75/181.75 [SD:0.71]、9.8/11.4 [SD:1.13]、2.1/1.9 [SD:0.14]分别）。 PET 处理检查中未报告假阳性病变。商定的 SubtlePET™ 每次检查价格为 FDG 节省的 15-20%。这是第一个真实世界的研究，证明了采用 66% 标准剂量获得的 AI 处理的 18F-FDG PET/CT 检查的非劣效性以及定义 AI 解决方案价格的方法。