Potential utility of 68Ga-DOTA-FAPI-04 as a broad-spectrum benign disease imaging agent—comparison with 18F-FDG and 99mTc-MDP

Abstract Purpose To compare the detection performance of 68Ga-DOTA-FAPI-04 positron emission tomography/computed tomography (PET/CT) and 18F-FDG PET/CT for patients with various benign diseases and that of 68Ga-DOTA-FAPI-04 PET/CT and 99mTc-MDP single-photon emission computed tomography/computed tomography (SPECT/CT) for patients with benign bone lesions. Methods In total, 111 patients underwent two types of radionuclide examination. This prospective study included 89 patients who underwent 18F-FDG PET/CT and 68Ga-DOTA-FAPI-04 PET/CT and 22 patients who underwent 99mTc-MDP SPECT/CT and 68Ga-DOTA-FAPI-04 PET/CT from January 2020 to June 2022. The lesion number, T value, and B value were recorded to calculate the true positive rate and T/B value. The detection performance of 68Ga-DOTA-FAPI-04, 18F-FDG PET/CT, and 99mTc-MDP SPECT/CT for benign lesions was compared using the T/B value, T value (SUVmax in PET/CT), and true positive rate. Paired sample t-tests were conducted for comparisons. Results This study comprised 111 patients, 53 men and 58 women (mean age, 53 ± 15.75 years). 68Ga-DOTA-FAPI-04 PET/CT demonstrated a higher uptake and detection rate for fibrotic disease (SUVmax [FAPI vs FDG: 6.26 ± 1.61 vs 2.38 ± 1.26], p1<.001; T/B value [FAPI vs FDG: 9.38 ± 2.78 vs 1.95 ± 1.33], p2<.001; and true positive rate 100% vs 26.3%), infectious disease (T/B value [FAPI vs FDG: 14.15 ± 12.42 vs 6.70 ± 5.87], p2 < .05; and true positive rate 94% vs 82%), and benign tumour (T/B value [FAPI vs FDG: 6.49 ± 5.85 vs 1.96 ± 2.03], p2 < .05; and true positive rate 70% vs 52%) than 18F-FDG PET/CT. 68Ga-DOTA-FAPI-04 PET/CT demonstrated a lower uptake and comparable detection rate for benign bone disease (T/B value [FAPI vs FDG: 5.46 ± 2.91 vs 23.58 ± 15.37], p < .001; and true positive rate 90% vs 99%) when compared with 99mTc-MDP SPECT/CT. Conclusion 68Ga-DOTA-FAPI-04 could be used in the clinical setting as a benign disease imaging agent and a complement to traditional nuclide imaging agents. Trial registration No.: ChiCTR2100044131