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Accuracy and Safety of Scout Dose Resin Yttrium-90 Microspheres for Radioembolization Therapy Treatment Planning: A Prospective Single-Arm Clinical Trial
Journal of Vascular and Interventional Radiology ( IF 2.6 ) Pub Date : 2022-09-06 , DOI: 10.1016/j.jvir.2022.08.027
Nima Kokabi 1 , Linzi A Webster 1 , Mohammad Elsayed 1 , Jeffrey M Switchenko 2 , Bernard Chen 1 , David Brandon 3 , James Galt 3 , Ila Sethi 3 , Mircea Cristescu 4 , S Cheenu Kappadath 5 , David M Schuster 3
Affiliation  

Purpose

To compare the accuracy and safety of 0.56 GBq resin yttrium-90 (90Y) (scout90Y) microspheres with those of technetium-99m macroaggregated albumin (MAA) in predicting the therapeutic 90Y (Rx90Y) 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 scout90Y. Rx90Y 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 scout90Y were compared with those by Rx90Y. Bland-Altman plots compared the level of agreement between the TNR and LSF of scout90Y and MAA with that of Rx90Y. The safety of scout90Y was evaluated by examining the discrepancy in extrahepatic activity between MAA and scout90Y.

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 Rx90Y. Scout90Y had a moderate LSF, strong TNR, strong TD, and very strong NTLD in correlation with those of Rx90Y. Furthermore, the TNR and LSF of scout90Y had a stronger agreement with those of Rx90Y than with those of MAA. In the nonsegmental subgroup, MAA had no significant correlation with the TD and NTLD of Rx90Y, whereas scout90Y had a very strong correlation with both of these factors. In the segmental subgroup, both MAA and scout90Y had a strong linear correlation with the TD and NTLD of Rx90Y.

Conclusions

Compared with MAA, scout90Y is a more accurate surrogate for Rx90Y biodistribution for nonsegmental therapies.



中文翻译:

用于放射栓塞治疗计划的 Scout Dose 树脂 Yttrium-90 微球的准确性和安全性:一项前瞻性单臂临床试验

目的

比较 0.56 GBq 树脂钇 90 ( 90 Y) (scout 90 Y) 微球与锝 99m 大聚集白蛋白 (MAA) 在预测肝细胞癌患者治疗性90 Y (Rx 90 Y) 剂量时的准确性和安全性癌(肝癌)。

材料和方法

这项前瞻性单臂临床试验 (Clinicaltrials.gov: NCT04172714) 招募了 HCC 患者。患者在同一天接受了 MAA 和90 Y 的测绘。测绘后 3 天进行了Rx 90 Y 活动。使用配对t检验和 Pearson 相关性,比较了MAA 和 scout 90 Y 的肿瘤与正常比率 (TNR)、肺分流分数 (LSF)、预测平均肿瘤剂量 (TD) 和非肿瘤肝脏剂量 (NTLD)那些由 Rx 90 Y 绘制的。Bland-Altman 图比较了 scout 90 Y 和 MAA 与 Rx 90 Y的 TNR 和 LSF 之间的一致性水平。scout 90的安全性通过检查 MAA 和 scout 90 Y之间肝外活性的​​差异来评估 Y。

结果

30 名患者使用 19 种节段性和 14 种非节段性(即 2 个连续节段或非节段性)疗法进行治疗。MAA 与 Rx 90 Y具有弱 LSF、中等 TNR 和中等 TD 线性相关性。Scout 90 Y 与 Rx 90 Y 具有中等 LSF、强 TNR、强 TD 和非常强的 NTLD 相关性。此外,TNR 和侦察员90 Y的 LSF与 Rx 90 Y 的一致性比与 MAA 的一致性更强。在非分段亚组中,MAA 与 Rx 90 Y的 TD 和 NTLD 没有显着相关性,而 scout 90 Y 与这两个因素都有很强的相关性。在分段子组中,MAA 和 scout 90Y 与 Rx 90 Y的 TD 和 NTLD 具有很强的线性相关性。

结论

与 MAA 相比,Scout 90 Y 更准确地替代了非分段疗法的 Rx 90 Y 生物分布。

更新日期:2022-09-06
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