目的:靶向成纤维细胞激活蛋白是一种新的肿瘤间质可视化诊断方法,和一种新型的铝-[18F]氟化物(Al18F)标记的成纤维细胞活化蛋白抑制剂-4(FAPI-04),下文中[18F]AlF-NOTA-FAPI-04由于其相对较长的半衰期而呈现镓68(68Ga)标记的FAPI的有希望的替代物。本研究旨在评估[18F]AlF-NOTA-FAPI-04PET/CT对诊断各种类型癌症的临床有用性,与[18F]FDGPET/CT相比。
方法:在这项从2021年10月至2024年1月进行的前瞻性研究中,共有148例患者,有16种不同的肿瘤实体,同时接受了18F-FDG和18F-FAPI-04PET/CT的初步评估或复发检测。通过最大标准摄取值(SUVmax)定量18F-FDG和18F-FAPI-04的摄取。诊断灵敏度,特异性,通过使用McNemar试验比较了这两种显像剂的准确性。
结果:18F-FAPI-04PET/CT可以清晰地描绘16种不同类型的癌症,具有出色的图像对比度,从而导致原发性肿瘤的检出率高于18F-FDGPET/CT(98.06%vs.81.55%,P<0.001)。在每个淋巴结分析中,灵敏度,特异性,淋巴结转移的诊断准确率为92.44%,90.44%,和91.56%,分别,远高于18F-FDGPET/CT(80.23%,79.41%,79.87%,分别)。同时,18F-FAPI-04PET/CT在识别更多可疑远处转移方面优于18F-FDGPET/CT(86.57%vs.74.13%,P<0.001)。此外,18F-FAPI-04PET/CT在36/101例患者中升级了肿瘤分期(35.6%),43/47例患者(91.49%)发现肿瘤复发或转移。
结论:我们的研究结果表明,在18F-FAPI-04PET/CT上,各种类型的恶性肿瘤患者的原发和转移性病变都可以很好地观察,其诊断性能优于18F-FDGPET/CT。此外,18F-FAPI-04PET/CT是用于肿瘤分期和各种恶性肿瘤随访的有前途的工具。
OBJECTIVE: Targeting fibroblast-activation protein is a newer diagnostic approach for the visualization of tumor stroma, and a novel aluminum-[18F] fluoride (Al18F)-labeled fibroblast-activation protein inhibitor-4 (FAPI-04), hereafter [18F] AlF-NOTA-FAPI-04, presents a promising alternative to gallium 68 (68Ga)-labeled FAPI owing to its relatively longer half-life. This
study sought to evaluate the clinical usefulness of [18F] AlF-NOTA-FAPI-04 PET/CT for the diagnosis of various types of cancer, compared to [18F] FDG PET/CT.
METHODS: In this prospective
study conducted from October 2021 to January 2024, a total of 148 patients with 16 different tumor entities underwent contemporaneous 18F-FDG and 18F-FAPI-04 PET/CT either for an initial assessment or for recurrence detection. Uptake of 18F-FDG and 18F-FAPI-04 was quantified by the maximum standard uptake value (SUV max). Diagnostic sensitivity, specificity, and accuracy were compared by using the McNemar test between these two imaging agents.
RESULTS: 18F-FAPI-04 PET/CT could clearly depict 16 different types of cancer with excellent image contrast, thereby leading to a higher detection rate of primary tumors than did 18F-FDG PET/CT (98.06% vs. 81.55%, P<0.001). In per-lymph node analysis, the sensitivity, specificity, and accuracy in the diagnosis of metastatic lymph nodes were 92.44%, 90.44%, and 91.56%, respectively, which was much higher than that 18F-FDG PET/CT (80.23%, 79.41%, and 79.87%, respectively). Meanwhile, 18F-FAPI-04 PET/CT outperformed 18F-FDG PET/CT in identifying more suspected distant metastases (86.57% vs. 74.13%, P<0.001). Furthermore, 18F-FAPI-04 PET/CT upgraded tumor staging in 36/101 patients (35.6%), and detected tumor recurrence or metastases in 43/47 patients (91.49%).
CONCLUSIONS: Our findings demonstrated that primary and metastatic lesions in patients with various types of malignant tumors are well-visualized on 18F-FAPI-04 PET/CT, which exhibited a superior diagnostic performance than 18F-FDG PET/CT. Moreover, 18F-FAPI-04 PET/CT is a promising tool for tumor staging and follow-up of various malignancies.