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

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.This prospective study included 89 patients who underwent [18F]FDG and [68Ga]DOTA-FAPI-04 PET/CT and 22 patients who underwent [99mTc]MDP SPECT/CT and [68Ga]DOTA-FAPI-04 PET/CT. 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, and true positive rate. Paired sample t-tests were conducted for comparisons.This study comprised 53 men and 58 women (mean age, 53 ± 15.75 years). [68Ga]DOTA-FAPI-04 demonstrated a higher uptake and detection rate for fibrotic disease (SUVmax [FAPI vs FDG: 6.26 ± 1.61 vs 2.38 ± 1.26], p1 < 0.001; T/B value [FAPI vs FDG: 9.38 ± 2.78 vs 1.95 ± 1.33], p2 < 0.001; 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 < 0.05; and true positive rate 94% vs 82%), and benign tumor (T/B value [FAPI vs FDG: 6.49 ± 5.85 vs 1.96 ± 2.03], p2 < 0.05; and true positive rate 70% vs 52%) than [18F]FDG. [68Ga]DOTA-FAPI-04 demonstrated a lower uptake and a comparable detection rate for benign bone disease (T/B value [FAPI vs FDG: 5.46 ± 2.91 vs 23.58 ± 15.37], p < 0.001; and true positive rate 90% vs 99%) than [99mTc]MDP.[68Ga]DOTA-FAPI-04 could be used as a benign disease imaging agent to complement traditional nuclide imaging agents.Our study showed that [68Ga]DOTA-FAPI-04 PET/CT could provide reliable imaging evidence for clinical detection and diagnosis of various benign lesions, such as inflammatory, infectious, fibrotic diseases, and benign tumors.• [68Ga]DOTA-FAPI-04 demonstrated a higher uptake and detection rate for fibrotic disease, infectious disease, and benign tumor than [18F]FDG. • [68Ga]DOTA-FAPI-04 demonstrated an equivalent detection efficacy to [18F]FDG for inflammatory diseases. • [68Ga]DOTA-FAPI-04 demonstrated a lower uptake and a comparable detection rate for benign bone disease than [99mTc]MDP.