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Article Abstract

Objective: Gallium-68-labelled fibroblast activation protein inhibitor ([ Ga]Ga-FAPI) is a tumour-stromal imaging agent showing complementary value alongside fluorine-18 fluorodeoxyglucose ([F]FDG) in cancer imaging. This study investigated the feasibility of a same-day dual-tracer positron emission tomography/computed tomography (PET/CT) protocol with [ Ga]Ga-FAPI-04 following [F]FDG in patients presenting with negative or equivocal [F]FDG.

Methods: Patients with negative or equivocal [F]FDG findings underwent dual-tracer PET/CT (named FDG-mixed FAPI PET/CT, abbreviated to mFAPI PET/CT) on the same day, with [ Ga]Ga-FAPI-04 administered 4.0-7.75 h following [F]FDG injection. Lesion detection rates and lesion-to-background uptake ratios (LBRs) were compared between [F]FDG and mFAPI PET/CT.

Results: Forty-four patients were included in the analysis. The mFAPI PET was superior to [F]FDG PET for primary tumour detection (86.2% [25/29] vs. 37.9% [11/29], P < 0.001), and showed higher LBRs (P < 0.001) in various types of cancer. For metastatic lesions detection, mFAPI PET yielded a greater number of positive lesions (90.3% [317/351] vs. 44.7% [157/351], P < 0.001) and higher LBRs than [F]FDG in most lesions, especially in lymph node, peritoneal, and liver metastases (all P < 0.05). The mFAPI PET/CT scans had a prominent impact on patients with negative or equivocal [F]FDG in different clinical situations, including characterizing suspicious lesions in 88.9% (8/9), locating the primary site in 46.2% (6/13), upgrading of tumour staging in 81.8% (9/11), and identification of recurrence in 81.8% (9/11).

Conclusions: A same-day dual-tracer PET/CT protocol with [ Ga]Ga-FAPI-04 following [F]FDG is feasible for enhancing the ability to identify indeterminate lesions, localize unknown malignant primary tumour sites, and accurately provide staging and restaging in patients presenting with negative or equivocal [F]FDG.

Trial Registration: NCT05034146. Registered February 23, 2021.

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http://dx.doi.org/10.1007/s12149-025-02080-1DOI Listing

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