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Clinical prospective study of Gallium 68 (68Ga)–labeled fibroblast-activation protein inhibitor PET/CT in the diagnosis of biliary tract carcinoma

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A Correction to this article was published on 17 March 2023

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Abstract

Purpose

This study is to investigate the [68Ga]Ga-DOTA-FAPI PET/CT diagnosis performance in biliary tract carcinoma (BTC) and analyze the association between [68Ga]Ga-DOTA-FAPI PET/CT and clinical indexes.

Methods

A prospective study (NCT 05264688) was performed between January 2022 and July 2022. Fifty participants were scanned using [68Ga]Ga-DOTA-FAPI and [18F]FDG PET/CT and acquired pathological tissue. We employed the Wilcoxon signed-rank test to compare the uptake of [68Ga]Ga-DOTA-FAPI and [18F]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 [68 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 [68Ga]Ga-DOTA-FAPI detection rate was greater than [18F]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 [68Ga]Ga-DOTA-FAPI was higher than [18F]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 [68Ga]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 [68Ga]Ga-DOTA-FAPI metabolic tumor volume and carbohydrate antigen199 (CA199) (Pearson r = 0.436, p = 0.002) was confirmed.

Conclusion

[68Ga]Ga-DOTA-FAPI had a higher uptake and sensitivity than [18F]FDG in the diagnosis of BTC primary and metastatic lesions. The correlation between [68Ga]Ga-DOTA-FAPI PET/CT indexes and FAP expression, CEA, PLT, and CA199 were confirmed.

Trial registration

clinicaltrials.gov: NCT 05,264,688.

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Data availability

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

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Acknowledgements

The authors gratefully acknowledge all participants.

Funding

This work was supported by grants from the Key Research and Development Program of Hubei Province (2021BCA114), Research Fund of the Health Commission of Hubei Province (WJ2021M255), and Cancer Research and Translational Platform Project of Zhongnan Hospital of Wuhan University (ZLYNXM202004).

Author information

Authors and Affiliations

Authors

Contributions

All authors contributed to the study conception and design. Yuan Yufeng, He Yong, and Zhang Zhonglin designed the clinical research. Jiang Yaqun and Xia Xigang conducted the literature search. Liao Bo, Zhu Qian, Wang Haitao, Wu Dongde, Jiang Ping, Tang Shengli, Yang Zhiyong, and He Yueming recruited the patients. Li Jinghua, Xu Kui, Guo Deliang, and Jiang Yaqun conducted the study and collected and analyzed data. All authors read and approved the final manuscript.

Corresponding authors

Correspondence to Zhang Zhonglin, He Yong or Yuan Yufeng.

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Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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The authors affirm that human research participants provided informed consent for publication of the images in all figures.

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The authors declare no competing interests.

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The original online version of this article was revised: The authors regret to inform that there is an error in their original article. The following article note is missing in the original article:  Li Jinghua, Xu Kui, and Guo Deliang contributed equally to the work.

The original article has been corrected.

This article is part of the Topical Collection on Oncology - General.

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Jinghua, L., Kui, X., Deliang, G. et al. Clinical prospective study of Gallium 68 (68Ga)–labeled fibroblast-activation protein inhibitor PET/CT in the diagnosis of biliary tract carcinoma. Eur J Nucl Med Mol Imaging 50, 2152–2166 (2023). https://doi.org/10.1007/s00259-023-06137-z

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