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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人工智能以降低剂量的18F-FDG PET检查：通过标准化框架和业务案例评估进行的实际部署

要确定人工智能（AI）处理的PET / CT图像是否比标准注射剂量减少了18-F-FDG活性的三分之一，是否不劣于自然扫描，如果是，则要评估其商业化的潜在影响。SubtlePET™AI引入了意大利的PET / CT中心。前瞻性招募了接受18F-FDG PET / CT转诊的合格患者。施用的18F-FDG降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处理”具有减少的剂量和标准采集时间，“ PET天然”具有经过的时间，以模拟标准采集时间和剂量。使用SubtlePET™重建PET处理的图像。PET原始图像被定义为参考标准。数据集被匿名，并由四个盲人以随机顺序进行独立评估。评估包括主观图像质量（IQ）评估，病变可检测性和业务收益评估。从2020年2月至2020年4月，预期招募了61名患者。对于所有扫描仪模型，主观智商在数据集之间没有显着差异（4.62±0.23，p = 0.237），具有“几乎完美的”阅读器间一致性。数据集在病灶的可检测性，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处理的检查未报告假阳性病变。同意的SubtlePET™每次检查价格为FDG节省的15-20％。