Qin_2022_Eur.J.Nucl.Med.Mol.Imaging_49_4228

PURPOSE: Gallium-68-labeled fibroblast activation protein inhibitor ((68)Ga-FAPI) is an emerging promising tumor tracer. This study aims to evaluate the diagnostic efficiency of (68)Ga-FAPI PET in gastrointestinal cancer, and to determine its potential impact on clinical management. METHODS: Patients with malignancies were prospectively enrolled in a clinical trial to evaluate the diagnostic value of (68)Ga-FAPI PET. One hundred twenty patients with gastrointestinal malignancies (121 (68)Ga-FAPI PET scans) between June 2020 and May 2021 were retrospectively analyzed. Initial staging of untreated patients and restaging of treated patients were evaluated. The treatment scheme promoted by imaging was determined according to NCCN guidelines. Final diagnosis and treatment reference standards were determined by a dedicated multidisciplinary team. The diagnostic performance and treatment guidance of (68)Ga-FAPI PET were compared with those of conventional imaging (CI) and (18)F-FDG PET. RESULTS: The diagnostic accuracy of (68)Ga-FAPI PET was much higher than that of CI and (18)F-FDG PET (95.0% vs. 65.1% and 69.0%, respectively, both p < 0.001). (68)Ga-FAPI PET revised diagnosis in 30.3% and 26.2% of patients compared with CI and (18)F-FDG PET. The accordance rate of (68)Ga-FAPI PET-guided treatment in comparison with the reference standard was significantly higher than that of CI and (18)F-FDG PET (96.7% vs. 75.2% and 76.2%, respectively, both p < 0.001). (68)Ga-FAPI PET changed treatment in 22.9% and 23.8% of patients compared with CI and (18)F-FDG PET. CONCLUSIONS: (68)Ga-FAPI PET showed remarkable diagnostic performance in gastrointestinal cancer, resulting in more accurate staging and guidance for timely treatment revision, thereby having a critical impact on clinical management. TRIAL REGISTRATION: NCT04554719. Registered September 8, 2020-retrospectively registered, http://clinicaltrails.gov/show/NCT04554719.