A pilot study of [68Ga]Ga-FAPI-04 PET/CT in renal cell carcinoma.

OBJECTIVE: As a promising positron emission tomography (PET) tracer, [68Ga]Ga-fibroblast activation protein inhibitor-04([68Ga]Ga-FAPI-04) performs better than 2-[18F]fluoro-2-deoxy-D-glucose ([18F]FDG) at diagnosing primary and metastatic lesions in patients with various types of cancer. We investigated the utility of [68Ga]Ga-FAPI-04 PET/CT for the detection of primary and metastatic lesions in renal cell carcinoma (RCC). [18F]FDG PET/CT were used for comparison.

METHODS: Twenty-two patients with suspected RCC or recurrent RCC were enrolled in our study. Among these patients, 14 were newly diagnosed with RCC, 3 had recurrent RCC, and 5 were excluded from further analysis due to having benign renal tumours. Seventeen patients with RCC underwent [68Ga]Ga-FAPI-04 PET/CT, and 6 of them also received [18F]FDG PET/CT. The positive detection rates were calculated and compared with those in patients who underwent both scans.

RESULTS: Data from 17 patients with RCC (median age: 60.5 years, interquartile range [IQR]: 54-70 years) were evaluated. The positive detection rate of [68Ga]Ga-FAPI-04 PET/CT for RCC was 64.7% (11/17). Lymph node metastases (n = 44), lung metastasis (n = 1), and bone metastasis (n = 1) were detected. Six patients with RCC underwent [68Ga]Ga-FAPI-04 and [18F]FDG PET/CT. [68Ga]Ga-FAPI-04 PET/CT showed a higher positive detection rate than [18F]FDG PET/CT in detecting RCC (83.3% [5/6] vs. 50% [3/6], P = 0.545). Additionally, [68Ga]Ga-FAPI-04 PET/CT has higher SUVmax (3.20 [IQR: 2.91-5.80 vs. 2.71 [IQR: 2.13-3.10], p = 0.116) and TBR values (1.60 [IQR: 1.33-3.67] vs. 0.86 [0.48-1.21], p = 0.028) than [18F]FDG PET/CT.

CONCLUSION: These findings suggest that [68Ga]Ga-FAPI-04 PET/CT has potential value in RCC diagnosis. Further studies are warranted to validate these results.

ADVANCES IN KNOWLEDGE: Clinical utility of [68Ga]Ga-FAPI-04 in RCC remains unclear, and there aren't many similar studies in the literature. We evaluated the role of [68Ga]Ga-FAPI-04 in diagnosing RCC.