PDF(Sci-hub)
Abstract：
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
摘要：
背景：为了确定与标准注射剂量相比，人工智能（AI）处理的PET/CT图像是否减少了18-F-FDG活性的三分之一，不劣于原生扫描，如果是，评估商业化的潜在影响。
方法：SubtlePET™AI被引入意大利的PET/CT中心。前瞻性纳入符合18F-FDGPET/CT标准的患者。施用的18F-FDG减少到标准剂量的三分之二。患者接受了一次低剂量CT和两次顺序PET扫描；“PET处理”，剂量减少，采集时间标准，和“PET-native”，带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天然图像被定义为参考标准。数据集是匿名化的，并由四个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,和商业利益评估。
结果：从2020年2月至4月，有61例患者被前瞻性纳入。所有扫描仪模型的主观智商在数据集（4.62±0.23，p=0.237）之间没有显着差异，与“几乎完美”的读者之间的协议。病变可检测性数据集之间没有显著差异，目标病变平均SUVmax值，和肝脏平均SUV平均值（182.75/181.75[SD：0.71]，9.8/11.4[标准差：1.13]，2.1/1.9[标准差：0.14]）。在PET处理的检查中没有报告假阳性病变。每次检查商定的SubtlePET™价格为FDG节省的15-20%。
结论：这是第一个真实的研究，以证明AI处理的18F-FDGPET/CT检查具有66％标准剂量和定义方法的非劣效性AI解决方案价格。
方法：SubtlePET™AI被引入意大利的PET/CT中心。前瞻性纳入符合18F-FDGPET/CT标准的患者。施用的18F-FDG减少到标准剂量的三分之二。患者接受了一次低剂量CT和两次顺序PET扫描；“PET处理”，剂量减少，采集时间标准，和“PET-native”，带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天然图像被定义为参考标准。数据集是匿名化的，并由四个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,和商业利益评估。
结果：从2020年2月至4月，有61例患者被前瞻性纳入。所有扫描仪模型的主观智商在数据集（4.62±0.23，p=0.237）之间没有显着差异，与“几乎完美”的读者之间的协议。病变可检测性数据集之间没有显著差异，目标病变平均SUVmax值，和肝脏平均SUV平均值（182.75/181.75[SD：0.71]，9.8/11.4[标准差：1.13]，2.1/1.9[标准差：0.14]）。在PET处理的检查中没有报告假阳性病变。每次检查商定的SubtlePET™价格为FDG节省的15-20%。
结论：这是第一个真实的研究，以证明AI处理的18F-FDGPET/CT检查具有66％标准剂量和定义方法的非劣效性AI解决方案价格。
