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钇[90]树脂微球放射性栓塞治疗计划中示踪剂量的准确性和安全性:一项前瞻性单臂临床试验。

Accuracy and Safety of Scout Dose Resin Yttrium-90 Microspheres for Radioembolization Therapy Treatment Planning: A Prospective Single-Arm Clinical Trial.

机构信息

Division of Interventional Radiology and Image-Guided Medicine, Department of Radiology and Imaging Sciences, Emory University School of Medicine, Atlanta, Georgia.

Division of Interventional Radiology and Image-Guided Medicine, Department of Radiology and Imaging Sciences, Emory University School of Medicine, Atlanta, Georgia.

出版信息

J Vasc Interv Radiol. 2022 Dec;33(12):1578-1587.e5. doi: 10.1016/j.jvir.2022.08.027. Epub 2022 Sep 6.

Abstract

PURPOSE

To compare the accuracy and safety of 0.56 GBq resin yttrium-90 (Y) (scoutY) microspheres with those of technetium-99m macroaggregated albumin (MAA) in predicting the therapeutic Y (RxY) dose for patients with hepatocellular carcinoma (HCC).

MATERIALS AND METHODS

This prospective single-arm clinical trial (Clinicaltrials.gov: NCT04172714) recruited patients with HCC. Patients underwent same-day mapping with MAA and scoutY. RxY activity was administered 3 days after mapping. Using paired t test and Pearson correlation, the tumor-to-normal ratio (TNR), lung shunt fraction (LSF), predicted mean tumor dose (TD), and nontumoral liver dose (NTLD) by MAA and scoutY were compared with those by RxY. Bland-Altman plots compared the level of agreement between the TNR and LSF of scoutY and MAA with that of RxY. The safety of scoutY was evaluated by examining the discrepancy in extrahepatic activity between MAA and scoutY.

RESULTS

Thirty patients were treated using 19 segmental and 14 nonsegmental (ie, 2 contiguous segments or nonsegmental) therapies. MAA had weak LSF, moderate TNR, and moderate TD linear correlation with RxY. ScoutY had a moderate LSF, strong TNR, strong TD, and very strong NTLD in correlation with those of RxY. Furthermore, the TNR and LSF of scoutY had a stronger agreement with those of RxY than with those of MAA. In the nonsegmental subgroup, MAA had no significant correlation with the TD and NTLD of RxY, whereas scoutY had a very strong correlation with both of these factors. In the segmental subgroup, both MAA and scoutY had a strong linear correlation with the TD and NTLD of RxY.

CONCLUSIONS

Compared with MAA, scoutY is a more accurate surrogate for RxY biodistribution for nonsegmental therapies.

摘要

目的

比较 0.56GBq 钇-90(Y)(示踪 Y)树脂微球与锝-99m 聚合白蛋白(MAA)在预测肝细胞癌(HCC)患者治疗性 Y(RxY)剂量方面的准确性和安全性。

材料与方法

这项前瞻性单臂临床试验(Clinicaltrials.gov:NCT04172714)招募了 HCC 患者。患者在同一天接受 MAA 和示踪 Y 进行映射。映射后 3 天给予 RxY 活性。使用配对 t 检验和 Pearson 相关分析,比较 MAA 和示踪 Y 的肿瘤-正常比值(TNR)、肺分流分数(LSF)、预测平均肿瘤剂量(TD)和非肿瘤性肝脏剂量(NTLD)与 RxY 的相关性。Bland-Altman 图比较了示踪 Y 和 MAA 的 TNR 和 LSF 与 RxY 的一致性水平。通过检查 MAA 和示踪 Y 之间肝外活性的差异来评估示踪 Y 的安全性。

结果

30 例患者接受了 19 个节段性和 14 个非节段性(即 2 个连续节段或非节段性)治疗。MAA 具有较弱的 LSF、中等 TNR 和中等 TD 与 RxY 的线性相关性。示踪 Y 具有中等 LSF、强 TNR、强 TD 和与 RxY 非常强的 NTLD 相关性。此外,示踪 Y 的 TNR 和 LSF 与 RxY 的一致性强于与 MAA 的一致性。在非节段性亚组中,MAA 与 RxY 的 TD 和 NTLD 无显著相关性,而示踪 Y 与这两个因素均有很强的相关性。在节段性亚组中,MAA 和示踪 Y 与 RxY 的 TD 和 NTLD 均具有很强的线性相关性。

结论

与 MAA 相比,示踪 Y 是一种更准确的非节段性治疗 RxY 生物分布的替代物。

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