In this study, we aimed to evaluate the diagnostic sensitivity of [⁶⁸ Ga]Ga-DOTA-FAPI-04 PET/CT in the evaluation of primary or recurrent tumor, and nodal, peritoneal, and distant organ metastases in patients with newly diagnosed or relapsed colorectal cancer (CRC) in comparison with [¹⁸F]FDG PET/CT.

Thirty-nine patients with histopathologically confirmed primary or relapsed CRC were included in our study. All patients underwent both [¹⁸F]FDG and [⁶⁸ Ga]Ga-DOTA-FAPI-04 PET/CT imaging in the same week. Primary lesions, lymph nodes, and metastatic lesions were recorded on both scans. SUVmax and background values were measured from the primary and metastatic lesions; tumor-to-background ratio (TBR) was calculated and compared. The results of the operation were compared with PET findings in patients who underwent surgical treatment without neoadjuvant chemotherapy (NAC).

The sensitivity and specificity of [⁶⁸ Ga]Ga-DOTA-FAPI-04 PET/CT in the evaluation of primary tumors were 100%, while the sensitivity of [¹⁸F]FDG PET/CT was 100% and its specificity was 85.3%. When evaluated with surgical results in the detection of lymph nodes, [⁶⁸ Ga]Ga-DOTA-FAPI-04 PET/CT had a sensitivity of 90% and a specificity of 100%, whereas [¹⁸F]FDG PET/CT had a sensitivity of 80% and a specificity of 81.8%. The sensitivity and specificity of [⁶⁸ Ga]Ga-DOTA-FAPI PET/CT for peritoneal implants were 100%, and the sensitivity of [¹⁸F]FDG PET/CT was 55%. The SUVmax of primary lesions was higher with [¹⁸F]FDG (p < 0.001), while TBR was higher in [⁶⁸ Ga]Ga-DOTA-FAPI PET/CT than [¹⁸F]FDG PET/CT (p: 0.008). SUVmax and TBR of the lymph nodes were significantly higher in [⁶⁸ Ga]Ga-DOTA-FAPI PET/CT than [¹⁸F]FDG PET/CT (p < 0.001 for both).

[⁶⁸ Ga]Ga-DOTA-FAPI-04 PET/CT achieved much higher sensitivity and specificity in the detection of primary lesions, and especially the lymph nodes and peritoneal metastases, suggesting that it can be employed in the assessment of primary tumor and metastases in patients with CRC in routine clinical practice.