Niftaliyeva Khanim, Kesim Selin, Filizoglu Nuh, Balaban Genc Zeynep Ceren, Ozguven Salih, Cagliyan Feyza, Ones Tunc, Dede Fuat, Turoglu Halil Turgut, Erdil Tanju Yusuf
Department of Nuclear Medicine, Marmara University School of Medicine, Istanbul, Turkey.
Department of Nuclear Medicine, University of Health Sciences, Kartal Dr. Lutfi Kirdar City Hospital, D-100 Güney Yanyol No:47 Cevizli Mevkii, Kartal, 34865, Istanbul, Turkey.
Ann Nucl Med. 2025 Sep 10. doi: 10.1007/s12149-025-02103-x.
This study aims to systematically evaluate the inter- and intra-observer agreement regarding lesions with uncertain malignancy potential in Ga-68 PSMA PET/CT imaging of prostate cancer patients, utilizing the PSMA-RADS 2.0 classification system, and to emphasize the malignancy evidence associated with these lesions.
We retrospectively reviewed Ga-68 PSMA PET/CT images of patients diagnosed with prostate cancer via histopathology between December 2016 and November 2023. Seventy-six patients and 98 target lesions, classified with PSMA-RADS scores 3A-3D by an experienced nuclear medicine specialist, were included. Three observers (two experienced and one less experienced nuclear medicine physician) evaluated the lesions at two different time points, three months apart, in a blinded manner. Intra-observer agreement was assessed using Cohen's kappa, while inter-observer agreement was analyzed using Fleiss' kappa.
All observers demonstrated significant intra-observer agreement, with percentages ranging from 67.3 to 80.6% and kappa values between 0.62 and 0.76. The highest intra-observer agreement was noted for bone lesions, while non-regional lymph nodes exhibited the lowest agreement. For inter-observer assessments, moderate agreement was observed across all lesions (Fleiss k = 0.51), with the highest agreement in regional lymph nodes and the lowest in non-regional lymph nodes and bone lesions. Follow-up results indicated malignancy detection rates of 63.4% for 3A, 47% for 3B, 44.5% for 3C, and 41.4% for 3D scored lesions.
The PSMA-RADS classification system demonstrated substantial intra-observer agreement and moderate inter-observer agreement for lesions with uncertain malignancy potential, supporting its clinical applicability. However, notable variability and limitations in reporting bone lesions, non-regional lymph nodes, and lung lesions were observed among readers. The ambiguous nature and management of PSMA-RADS 3 lesions underscore the need for further research to enhance risk stratification.
本研究旨在利用PSMA-RADS 2.0分类系统，系统评估前列腺癌患者Ga-68 PSMA PET/CT成像中具有不确定恶性潜能的病变在观察者间和观察者内的一致性，并强调与这些病变相关的恶性证据。
我们回顾性分析了2016年12月至2023年11月间经组织病理学诊断为前列腺癌的患者的Ga-68 PSMA PET/CT图像。纳入了76例患者和98个目标病变，由一位经验丰富的核医学专家根据PSMA-RADS评分为3A-3D进行分类。三名观察者（两名经验丰富和一名经验较少的核医学医师）在相隔三个月的两个不同时间点以盲法对病变进行评估。观察者内一致性采用Cohen's kappa评估，观察者间一致性采用Fleiss' kappa分析。
所有观察者均表现出显著的观察者内一致性，百分比范围为67.3%至80.6%，kappa值在0.62至0.76之间。骨病变的观察者内一致性最高，而非区域淋巴结的一致性最低。对于观察者间评估，所有病变的一致性为中等（Fleiss k = 0.51），区域淋巴结的一致性最高，非区域淋巴结和骨病变的一致性最低。随访结果显示，3A评分病变的恶性检出率为63.4%，3B为47%，3C为44.5%，3D为41.4%。
PSMA-RADS分类系统在具有不确定恶性潜能的病变中表现出较高的观察者内一致性和中等的观察者间一致性，支持其临床适用性。然而，读者在报告骨病变、非区域淋巴结和肺部病变时存在显著的变异性和局限性。PSMA-RADS 3类病变的性质和处理存在模糊性，强调需要进一步研究以加强风险分层。
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