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[⁶⁸Ga]Ga-FAPI-46 PET精度用于癌症成像与组织病理学验证:一个单中心,单臂,干预性,第二阶段试验

Kim M Pabst¹, Manuel M Weber², Christina Laschinsky¹

¹Department of Nuclear Medicine, West German Cancer Center, German Cancer Consortium and National Center for Tumor Diseases site, University Hospital Essen, Essen, Germany.

The Lancet. Oncology

|August 7, 2025

概括

[68Ga]Ga-FAPI-46 PET-CT成像剂在检测纤维细胞激活蛋白 (FAP) 表达瘤方面具有较高的积极预测价值,证实了其作为癌症诊断中可靠生物标志物的潜力.

科学领域:

在瘤学瘤学.
放射化学放射化学是指辐射化学.
核医学就是核医学.

背景情况:

纤维细胞激活蛋白α (FAP) 在癌症进展中起作用.
[68Ga]Ga-FAPI-46是一种用于正子发射断层扫描-计算机断层扫描 (PET-CT) 成像的新型放射追踪器.
以前的研究表明[68Ga]Ga-FAPI-46在癌症分期中的诊断准确度有希望.

研究的目的:

为了确定[68Ga]Ga-FAPI-46 PET的正预测值 (PPV),用于识别表达FAP的瘤.
探索PET扫描上放射性追踪剂吸收强度与免疫组织化学FAP表达水平之间的相关性.
评估[68Ga]Ga-FAPI-46作为成像生物标志物的安全性和潜力.

主要方法:

一个单一中心的二期干预试验,涉及已成年患者,患有各种已确认或怀疑的癌症类型,正在进行分期或重新分期.
患者接受了[68Ga]Ga-FAPI-46的静脉注射,随后进行PET-CT成像.
组织病理学确认和FAP表达的免疫组织化学分析被用作参考标准. 三个独立的读者分析了PET-CT图像.

主要成果:

[68Ga]Ga-FAPI-46 PET用于检测FAP阳性瘤的基于患者的PPV为90% (95%CI84-95),基于区域的PPV为92% (85-96).
可能与[68Ga]Ga-FAPI-46相关的不良事件在6%的参与者报告,没有严重的不良事件归因于追踪剂.
这项研究招募了155名参与者,平均年龄为62岁.

结论:

[68Ga]Ga-FAPI-46 PET是一种安全有效的成像生物标志物,用于检测表达FAP的瘤.
高PPV支持其在临床癌症诊断中的潜在实用性.
建议进行进一步的研究,以完善特异性并确定其在常规临床实践中的作用.

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