University of Arizona, Tucson, Arizona;
Warren Alpert Medical School of Brown University, Providence, Rhode Island.
J Nucl Med. 2023 Aug;64(8):1259-1265. doi: 10.2967/jnumed.122.265077. Epub 2023 May 25.
[ Ga]Ga-PSMA-11 ( Ga-PSMA-11) is used to identify prostate-specific membrane antigen (PSMA)-positive tumors on PET scans. In the VISION study, Ga-PSMA-11 was used to determine the eligibility of patients with metastatic castration-resistant prostate cancer for treatment with [Lu]Lu-PSMA-617 (Lu-PSMA-617), based on predefined read criteria. This substudy aimed to investigate the interreader variability and intrareader reproducibility of visual assessments of Ga-PSMA-11 PET/CT scans using the VISION read criteria and evaluate the agreement between read results for this and the VISION study. In VISION, Ga-PSMA-11 PET/CT scans were centrally read as inclusion cases if they had at least 1 PSMA-positive lesion and no PSMA-negative lesions that fulfilled the exclusion criteria. In this substudy, 125 PET/CT scans (75 inclusion and 50 exclusion cases) were randomly selected from VISION and retrospectively assessed by 3 independent central readers. A random subset of 20 cases (12 inclusion and 8 exclusion cases) was recoded for assessment of intrareader reproducibility. Classification of cases as inclusion or exclusion cases was based on the VISION read criteria. Overall interreader variability was assessed by Fleiss κ-statistics, and pairwise variability and intrareader reproducibility were assessed by Cohen κ-statistics. For interreader variability, the readers agreed on 77% of cases (overall average agreement rate, 0.85; Fleiss κ, 0.60 [95% CI, 0.50-0.70]). The pairwise agreement rate was 0.82, 0.88, and 0.84, and the corresponding Cohen κ was 0.54 (95% CI, 0.38-0.71), 0.67 (95% CI, 0.52-0.83), and 0.59 (95% CI, 0.43-0.75), respectively. For intrareader reproducibility, the agreement rate was 0.90, 0.90, and 0.95, and the corresponding Cohen κ was 0.78 (95% CI, 0.49-0.99), 0.76 (95% CI, 0.46-0.99), and 0.89 (95% CI, 0.67-0.99), respectively. The number of actual VISION inclusion cases out of the total number of cases scored as inclusion in this substudy was 71 of 93 (agreement rate, 0.76; 95% CI, 0.66-0.85) for reader 1, 70 of 88 (0.80; 0.70-0.87) for reader 2, and 73 of 96 (0.76; 0.66-0.84) for reader 3. All readers agreed on 66 of 75 VISION inclusion cases. Moderate-to-substantial interreader agreement and substantial-to-almost perfect intrareader reproducibility for Ga-PSMA-11 PET/CT scan assessment using the VISION read criteria were observed. The read rules applied in VISION can be readily learned and demonstrate good reproducibility.
[Ga]Ga-PSMA-11（Ga-PSMA-11）用于在 PET 扫描中识别前列腺特异性膜抗原（PSMA）阳性肿瘤。在 VISION 研究中，Ga-PSMA-11 用于根据预设的阅读标准，确定转移性去势抵抗性前列腺癌患者接受[Lu]Lu-PSMA-617（Lu-PSMA-617）治疗的资格。这项子研究旨在使用 VISION 阅读标准，调查 Ga-PSMA-11 PET/CT 扫描的视觉评估的读者间变异性和观察者内可重复性，并评估该阅读标准与 VISION 研究的阅读结果之间的一致性。在 VISION 中，如果 Ga-PSMA-11 PET/CT 扫描至少有 1 个 PSMA 阳性病变且没有满足排除标准的 PSMA 阴性病变，则被中心阅读为纳入病例。在这项子研究中，从 VISION 中随机选择了 125 个 PET/CT 扫描（75 个纳入病例和 50 个排除病例），由 3 位独立的中心读者进行回顾性评估。对 20 个病例的随机亚组（12 个纳入病例和 8 个排除病例）进行重新编码，以评估观察者内的可重复性。病例的分类为纳入或排除病例是基于 VISION 阅读标准的。总体读者间变异性通过 Fleiss κ 统计量进行评估，两两间变异性和观察者内可重复性通过 Cohen κ 统计量进行评估。对于读者间变异性，读者对 77%的病例达成一致（总体平均一致率为 0.85；Fleiss κ 值为 0.60[95%CI，0.50-0.70]）。两两间一致率为 0.82、0.88 和 0.84，相应的 Cohen κ 值为 0.54（95%CI，0.38-0.71）、0.67（95%CI，0.52-0.83）和 0.59（95%CI，0.43-0.75）。对于观察者内可重复性，一致性率为 0.90、0.90 和 0.95，相应的 Cohen κ 值为 0.78（95%CI，0.49-0.99）、0.76（95%CI，0.46-0.99）和 0.89（95%CI，0.67-0.99）。在这个子研究中，被评为纳入病例的病例总数为 93 例，其中实际为 VISION 纳入病例的有 71 例（一致性率为 0.76；95%CI，0.66-0.85），第一位读者为 70 例（0.80；0.70-0.87），第二位读者为 73 例（0.76；0.66-0.84），第三位读者为 73 例（0.76；0.66-0.84）。所有读者均一致同意 66 例 VISION 纳入病例。使用 VISION 阅读标准评估 Ga-PSMA-11 PET/CT 扫描时，观察到了中等至高度的读者间一致性和高度至几乎完美的观察者内可重复性。在 VISION 中应用的阅读规则易于学习，且具有良好的可重复性。
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