Interreader and intrareader reproducibility of ¹⁸F-flotufolastat PET/CT scans in newly diagnosed and recurrent prostate cancer patients was assessed from masked image evaluations from two phase 3 studies. Methods: ¹⁸F-flotufolastat PET/CT images of newly diagnosed (n = 352) or recurrent (n = 389) patients were evaluated by 3 masked readers. Cohen was used to assess pairwise patient- and region-level interreader agreement. Agreement among all readers was assessed using Fleiss . Intrareader agreement between the first and repeat read (20% of images, ≥4 wk later) was assessed using Cohen . Results: Pairwise interreader agreement was 95% or better (newly diagnosed) and 75% or better (recurrent). The coefficients were impacted by the high-agreement–low- paradox: Cohen ranged from not estimable to 0.55, whereas Fleiss was 0.50 (newly diagnosed) and 0.41 (recurrent). Agreement was highest in the prostate of newly diagnosed patients (≥95%) and in the pelvic lymph nodes in recurrent patients (≥87%). Intrareader agreement was 86% or better across both populations. Conclusion: ¹⁸F-flotufolastat PET/CT images can be reliably interpreted, with a high degree of inter- and intrareader agreement.

根据两项 3 期研究的遮蔽图像评估，评估了新诊断和复发前列腺癌患者的¹⁸ F-flotufolastat PET/CT 扫描的读者间和读者内再现性。方法：由 3 名蒙面读片员对^{18 幅}新诊断 ( n = 352) 或复发 ( n = 389) 患者的 F-氟洛司他 PET/CT 图像进行评估。 Cohen 用于评估成对患者和区域级别的读者间一致性。使用 Fleiss 评估所有读者之间的一致性。使用 Cohen 评估首次读取和重复读取（图像的 20%，≥4 周后）之间的读取器内一致性。结果：配对读者一致性为 95% 或更高（新诊断）和 75% 或更高（复发）。系数受到高一致性低悖论的影响：Cohen 的范围从不可估计到 0.55，而 Fleiss 为 0.50（新诊断）和 0.41（复发）。新诊断患者的前列腺（≥95%）和复发患者的盆腔淋巴结（≥87%）的一致性最高。两个群体的读者内部一致性为 86% 或更高。结论： ¹⁸ F-flotufolastat PET/CT 图像可以可靠地解读，并且阅读器间和阅读器内具有高度一致性。