镓 68（Ga）标记成纤维细胞激活蛋白抑制剂 PET/CT 临床前瞻性研究在胆道癌诊断中的应用。
Clinical prospective study of Gallium 68 (Ga)-labeled fibroblast-activation protein inhibitor PET/CT in the diagnosis of biliary tract carcinoma.
机构信息
Department of Hepatobiliary and Pancreatic Surgery, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.
Clinical Medicine Research Center for Minimally Invasive Procedure of Hepatobiliary &, Pancreatic Diseases of Hubei Province, Wuhan, Hubei, China.
出版信息
Eur J Nucl Med Mol Imaging. 2023 Jun;50(7):2152-2166. doi: 10.1007/s00259-023-06137-z. Epub 2023 Feb 21.
PURPOSE
This study is to investigate the [Ga]Ga-DOTA-FAPI PET/CT diagnosis performance in biliary tract carcinoma (BTC) and analyze the association between [Ga]Ga-DOTA-FAPI PET/CT and clinical indexes.
METHODS
A prospective study (NCT05264688) was performed between January 2022 and July 2022. Fifty participants were scanned using [Ga]Ga-DOTA-FAPI and [F]FDG PET/CT and acquired pathological tissue. We employed the Wilcoxon signed-rank test to compare the uptake of [Ga]Ga-DOTA-FAPI and [F]FDG, and the McNemar test was used to compare the diagnostic efficacy between the two tracers. Spearman or Pearson correlation was used to assess the association between [ Ga]Ga-DOTA-FAPI PET/CT and clinical indexes.
RESULTS
In total, 47 participants (mean age 59.09 ± 10.98 [range 33-80 years]) were evaluated. The [Ga]Ga-DOTA-FAPI detection rate was greater than [F]FDG in primary tumors (97.62% vs. 85.71%), nodal metastases (90.05% vs. 87.06%), and distant metastases (100% vs. 83.67%). The uptake of [Ga]Ga-DOTA-FAPI was higher than [F]FDG in primary lesions (intrahepatic cholangiocarcinoma, 18.95 ± 7.47 vs. 11.86 ± 0.70, p = 0.001; extrahepatic cholangiocarcinoma, 14.57 ± 6.16 vs. 8.80 ± 4.74, p = 0.004), abdomen and pelvic cavity nodal metastases (6.91 ± 6.56 vs. 3.94 ± 2.83, p < 0.001), and distant metastases (pleural, peritoneum, omentum, and mesentery, 6.37 ± 4.21 vs. 4.50 ± 1.96, p = 0.01; bone, 12.15 ± 6.43 vs. 7.51 ± 4.54, p = 0.008). There was a significant correlation between [Ga]Ga-DOTA-FAPI uptake and fibroblast-activation protein (FAP) expression (Spearman r = 0.432, p = 0.009), carcinoembryonic antigen (CEA) (Pearson r = 0.364, p = 0.012), and platelet (PLT) (Pearson r = 0.35, p = 0.016). Meanwhile, a significant relationship between [Ga]Ga-DOTA-FAPI metabolic tumor volume and carbohydrate antigen199 (CA199) (Pearson r = 0.436, p = 0.002) was confirmed.
CONCLUSION
[Ga]Ga-DOTA-FAPI had a higher uptake and sensitivity than [F]FDG in the diagnosis of BTC primary and metastatic lesions. The correlation between [Ga]Ga-DOTA-FAPI PET/CT indexes and FAP expression, CEA, PLT, and CA199 were confirmed.
TRIAL REGISTRATION
clinicaltrials.gov: NCT 05,264,688.
目的
本研究旨在探讨[Ga]Ga-DOTA-FAPI PET/CT 对胆道癌（BTC）的诊断性能，并分析[Ga]Ga-DOTA-FAPI PET/CT 与临床指标之间的相关性。
方法
一项前瞻性研究（NCT05264688）于 2022 年 1 月至 2022 年 7 月进行。50 名患者接受了[Ga]Ga-DOTA-FAPI 和[F]FDG PET/CT 扫描，并获取了病理组织。我们采用 Wilcoxon 符号秩检验比较[Ga]Ga-DOTA-FAPI 和[F]FDG 的摄取情况，采用 McNemar 检验比较两种示踪剂的诊断效能。采用 Spearman 或 Pearson 相关分析评估[Ga]Ga-DOTA-FAPI PET/CT 与临床指标之间的相关性。
结果
共有 47 名参与者（平均年龄 59.09±10.98[范围 33-80 岁]）接受了评估。在原发肿瘤（97.62%比 85.71%）、淋巴结转移（90.05%比 87.06%）和远处转移（100%比 83.67%）中，[Ga]Ga-DOTA-FAPI 的检出率均高于[F]FDG。在原发灶（肝内胆管癌，18.95±7.47 比 11.86±0.70，p=0.001；肝外胆管癌，14.57±6.16 比 8.80±4.74，p=0.004）、腹部和盆腔淋巴结转移（6.91±6.56 比 3.94±2.83，p<0.001）和远处转移（胸膜、腹膜、大网膜和肠系膜，6.37±4.21 比 4.50±1.96，p=0.01；骨，12.15±6.43 比 7.51±4.54，p=0.008）中，[Ga]Ga-DOTA-FAPI 的摄取量均高于[F]FDG。[Ga]Ga-DOTA-FAPI 摄取量与成纤维细胞激活蛋白（FAP）表达（Spearman r=0.432，p=0.009）、癌胚抗原（CEA）（Pearson r=0.364，p=0.012）和血小板（PLT）（Pearson r=0.35，p=0.016）呈显著正相关。同时，[Ga]Ga-DOTA-FAPI 代谢肿瘤体积与糖抗原 199（CA199）（Pearson r=0.436，p=0.002）之间也存在显著的相关性。
结论
[Ga]Ga-DOTA-FAPI 在诊断 BTC 原发和转移性病变时的摄取量和敏感性均高于[F]FDG。证实了[Ga]Ga-DOTA-FAPI PET/CT 指标与 FAP 表达、CEA、PLT 和 CA199 之间的相关性。
试验注册
clinicaltrials.gov：NCT 05264688。
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