Abstract：
OBJECTIVE: To compare the diagnostic accuracy and detection rates of PET/MRI with [68Ga]Ga-PSMA-11 and [68Ga]Ga-M2 in patients with biochemical recurrence of prostate cancer (PCa).
METHODS: Sixty patients were enrolled in this prospective single-center phase II clinical trial from June 2020 to October 2022. Forty-four/60 completed all study examinations and were available at follow-up (median: 22.8 months, range: 6-31.5 months). Two nuclear medicine physicians analyzed PET images and two radiologists interpreted MRI; images were then re-examined to produce an integrated PET/MRI report for both [68Ga]Ga-PSMA-11 and [68Ga]Ga-RM2 examinations. A composite reference standard including histological specimens, response to treatment, and conventional imaging gathered during follow-up was used to validate imaging findings. Detection rates, accuracy, sensitivity, specificity, positive, and negative predictive value were assessed. McNemar\'s test was used to compare sensitivity and specificity on a per-patient base and detection rate on a per-region base. Prostate bed, locoregional lymph nodes, non-skeletal distant metastases, and bone metastases were considered. p-value significance was defined below the 0.05 level after correction for multiple testing.
RESULTS: Patients\' median age was 69.8 years (interquartile range (IQR): 61.8-75.1) and median PSA level at time of imaging was 0.53 ng/mL (IQR: 0.33-2.04). During follow-up, evidence of recurrence was observed in 31/44 patients. Combining MRI with [68Ga]Ga-PSMA-11 PET and [68Ga]Ga-RM2 PET resulted in sensitivity = 100% and 93.5% and specificity of 69.2% and 69.2%, respectively. When considering the individual imaging modalities, [68Ga]Ga-RM2 PET showed lower sensitivity compared to [68Ga]Ga-PSMA-11 PET and MRI (61.3% vs 83.9% and 87.1%, p = 0.046 and 0.043, respectively), while specificity was comparable among the imaging modalities (100% vs 84.6% and 69.2%, p = 0.479 and 0.134, respectively).
CONCLUSIONS: This study brings further evidence on the utility of fully hybrid PET/MRI for disease characterization in patients with biochemically recurrent PCa. Imaging with [68Ga]Ga-PSMA-11 PET showed high sensitivity, while the utility of [68Ga]Ga-RM2 PET in absence of a simultaneous whole-body/multiparametric MRI remains to be determined.
METHODS: Sixty patients were enrolled in this prospective single-center phase II clinical trial from June 2020 to October 2022. Forty-four/60 completed all study examinations and were available at follow-up (median: 22.8 months, range: 6-31.5 months). Two nuclear medicine physicians analyzed PET images and two radiologists interpreted MRI; images were then re-examined to produce an integrated PET/MRI report for both [68Ga]Ga-PSMA-11 and [68Ga]Ga-RM2 examinations. A composite reference standard including histological specimens, response to treatment, and conventional imaging gathered during follow-up was used to validate imaging findings. Detection rates, accuracy, sensitivity, specificity, positive, and negative predictive value were assessed. McNemar\'s test was used to compare sensitivity and specificity on a per-patient base and detection rate on a per-region base. Prostate bed, locoregional lymph nodes, non-skeletal distant metastases, and bone metastases were considered. p-value significance was defined below the 0.05 level after correction for multiple testing.
RESULTS: Patients\' median age was 69.8 years (interquartile range (IQR): 61.8-75.1) and median PSA level at time of imaging was 0.53 ng/mL (IQR: 0.33-2.04). During follow-up, evidence of recurrence was observed in 31/44 patients. Combining MRI with [68Ga]Ga-PSMA-11 PET and [68Ga]Ga-RM2 PET resulted in sensitivity = 100% and 93.5% and specificity of 69.2% and 69.2%, respectively. When considering the individual imaging modalities, [68Ga]Ga-RM2 PET showed lower sensitivity compared to [68Ga]Ga-PSMA-11 PET and MRI (61.3% vs 83.9% and 87.1%, p = 0.046 and 0.043, respectively), while specificity was comparable among the imaging modalities (100% vs 84.6% and 69.2%, p = 0.479 and 0.134, respectively).
CONCLUSIONS: This study brings further evidence on the utility of fully hybrid PET/MRI for disease characterization in patients with biochemically recurrent PCa. Imaging with [68Ga]Ga-PSMA-11 PET showed high sensitivity, while the utility of [68Ga]Ga-RM2 PET in absence of a simultaneous whole-body/multiparametric MRI remains to be determined.
摘要：
目的：比较PET/MRI与[68Ga]Ga-PSMA-11和[68Ga]Ga-M2在前列腺癌生化复发患者中的诊断准确率和检出率。
方法：从2020年6月至2022年10月，该前瞻性单中心II期临床试验招募了60名患者。44/60人完成了所有研究检查，并在随访时可用（中位数：22.8个月，范围：6-31.5个月）。两名核医学医生分析了PET图像，两名放射科医生解释了MRI；然后重新检查图像，以针对[68Ga]Ga-PSMA-11和[68Ga]Ga-RM2检查生成完整的PET/MRI报告。包括组织学标本的复合参考标准，对治疗的反应，随访期间收集的常规影像学资料用于验证影像学发现.检测率,准确度,灵敏度,特异性，积极的,并评估阴性预测值。McNemar检验用于比较每个患者基础上的灵敏度和特异性以及每个区域基础上的检出率。前列腺床,局部淋巴结，非骨骼远处转移，并考虑骨转移。在多次测试校正后,P值显著性定义为低于0.05水平。
结果：患者的中位年龄为69.8岁（四分位距（IQR）：61.8-75.1），成像时的中位PSA水平为0.53ng/mL（IQR：0.33-2.04）。随访期间,在31/44例患者中观察到复发证据.MRI与[68Ga]Ga-PSMA-11PET和[68Ga]Ga-RM2PET的组合导致灵敏度=100％和93.5％，特异性为69.2％和69.2％。分别。当考虑个体成像模式时，与[68Ga]Ga-PSMA-11PET和MRI相比，[68Ga]Ga-RM2PET的灵敏度较低（61.3％vs83.9％和87.1％，p分别=0.046和0.043)，而特异性在成像方式之间具有可比性（100％vs84.6％和69.2％，p分别为0.479和0.134)。
结论：这项研究为完全混合PET/MRI用于生化复发性PCa患者的疾病表征提供了进一步的证据。用[68Ga]Ga-PSMA-11PET成像显示高灵敏度，而[68Ga]Ga-RM2PET在不存在同时全身/多参数MRI的情况下的效用仍有待确定。
方法：从2020年6月至2022年10月，该前瞻性单中心II期临床试验招募了60名患者。44/60人完成了所有研究检查，并在随访时可用（中位数：22.8个月，范围：6-31.5个月）。两名核医学医生分析了PET图像，两名放射科医生解释了MRI；然后重新检查图像，以针对[68Ga]Ga-PSMA-11和[68Ga]Ga-RM2检查生成完整的PET/MRI报告。包括组织学标本的复合参考标准，对治疗的反应，随访期间收集的常规影像学资料用于验证影像学发现.检测率,准确度,灵敏度,特异性，积极的,并评估阴性预测值。McNemar检验用于比较每个患者基础上的灵敏度和特异性以及每个区域基础上的检出率。前列腺床,局部淋巴结，非骨骼远处转移，并考虑骨转移。在多次测试校正后,P值显著性定义为低于0.05水平。
结果：患者的中位年龄为69.8岁（四分位距（IQR）：61.8-75.1），成像时的中位PSA水平为0.53ng/mL（IQR：0.33-2.04）。随访期间,在31/44例患者中观察到复发证据.MRI与[68Ga]Ga-PSMA-11PET和[68Ga]Ga-RM2PET的组合导致灵敏度=100％和93.5％，特异性为69.2％和69.2％。分别。当考虑个体成像模式时，与[68Ga]Ga-PSMA-11PET和MRI相比，[68Ga]Ga-RM2PET的灵敏度较低（61.3％vs83.9％和87.1％，p分别=0.046和0.043)，而特异性在成像方式之间具有可比性（100％vs84.6％和69.2％，p分别为0.479和0.134)。
结论：这项研究为完全混合PET/MRI用于生化复发性PCa患者的疾病表征提供了进一步的证据。用[68Ga]Ga-PSMA-11PET成像显示高灵敏度，而[68Ga]Ga-RM2PET在不存在同时全身/多参数MRI的情况下的效用仍有待确定。
