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The additional role of [68Ga]Ga-FAPI-04 PET/CT in patients with unknown primary lesion with a negative or equivocal [18F]FDG

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Abstract

Purpose

[18F]FDG PET/CT to detect unknown primary lesions is essential for clinical management but still has limitations. [68Ga]Ga-FAPI is a tumor-stromal imaging agent that provides a promising alternative to [18F]FDG for the assessment of malignancies. We aimed to investigate whether [68Ga]Ga-FAPI PET/CT has an additional role in identifying unknown primary lesions with negative or equivocal [18F] FDG PET/CT results.

Methods

This single-center prospective clinical study was conducted between March 2020 and March 2022 at Southwest Medical University Hospital. Patients underwent [18F]FDG PET/CT for the identification of unknown primary lesions. They underwent repeat [68Ga]Ga-FAPI PET/CT when [18F]FDG PET/CT results were negative or equivocal. Histopathological examination, surgery, or clinical follow-up (at least 3 months) for FAPI-positive lesions. The diagnostic efficacy of [68Ga]Ga-FAPI in identifying unknown primary lesions was evaluated.

Results

A total of 44 participants (median age, 57 ± 12 [SD]; 22 [50%] men) were evaluated. Thirteen of the 44 patients had equivocal [18F]FDG PET/CT findings, while the diagnosis was clear on [68Ga]Ga-FAPI PET/CT. [68Ga]Ga-FAPI PET/CT also revealed primary lesions in additional 17 patients with negative [18F]FDG PET/CT findings. In fourteen of 44 patients, no primary lesion was detected by either tracer. On this basis, we analyzed 94 lymph node metastatic lesions. The mean SUVmax of lymph node metastases on [68Ga] Ga-FAPI PET/CT and [18F]FDG PET/CT were 9.2 ± 5.1, 7.9 ± 4.8 (p = 0.03) and the mean TBR were 9.1 ± 5.2, 4.9 ± 3.1 (p < 0.01), respectively.

Conclusion

[68Ga]Ga-FAPI PET/CT showed great potential for identifying unknown primary lesions and has the potential to improve the detection rate of unknown primary lesions with negative or equivocal for [18F]FDG findings.

Trial registration

ClinicalTrial.gov. Identifier: ChiCTR2100044131

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Authors

Contributions

All authors contributed to the study conception and design. Material preparation, data collection, and analysis were performed by Qiaoqiao Shu, Maoxue Deng, Mei Hu, MengNa Liu, Xi Chen, Yue Chen, and Liang Cai. The first draft of the manuscript was written by Qiaoqiao Shu, Maoxue Deng, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

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Correspondence to Liang Cai.

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Shu, Q., Deng, M., Hu, M. et al. The additional role of [68Ga]Ga-FAPI-04 PET/CT in patients with unknown primary lesion with a negative or equivocal [18F]FDG. Eur J Nucl Med Mol Imaging 50, 1442–1452 (2023). https://doi.org/10.1007/s00259-022-06095-y

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