[ 68 Ga]Ga-FAPI-04 PET/CT on assessing Crohn’s disease intestinal lesions

Background Fibrosis and inflammation are major pathological changes of Crohn’s disease (CD). Early detection and accurate severity evaluation of CD are critical for patient’s prognosis. Endoscopy is widely used to evaluate CD progression. Herein, we evaluated the efficacy of [ 68 Ga]Ga-FAPI-04 PET/CT to identify lesions and assess the progression of CD. Methods All CD patients received computed tomography enterography (CTE), [ 68 Ga]Ga-FAPI-04 PET/CT examination, and ileocolonoscopy within 1 week. Two independent gastroenterologists computed the Crohn’s disease activity index (CDAI) of all patients. Two radiology physicians assessed the CTE images separately, and the CTE scores were calculated. Lastly, two nuclear medicine physicians independently examined the [ 68 Ga]Ga-FAPI-04 PET/CT images. Once the FAPI uptake of the intestinal segment was equal or higher relative to the liver (considered FAPI-positive), the target-to-background ratio (TBR) and global FAPI PET/CT score were computed, representing the independent intestinal activity and activity of all intestinal segments, respectively. Levels of fecal calprotectin (FCP) and C-reactive protein (CRP) were determined before the endoscopy. The Crohn’s disease endoscopy index of severity (CDEIS) and the simple endoscopic score for Crohn’s disease (SES-CD) were calculated during the endoscopy. Finally, all data were obtained and analyzed. Results There were 74 intestinal segments in 16 patients were assessed. [ 68 Ga]Ga-FAPI-04 PET/CT identified 42 of 45 endoscopically lesioned segments (endoscopic lesions detection sensitivity: 93.3%), while CTE identified 39 of them (endoscopic lesions detection sensitivity: 86.7%). According to the receiver operating characteristic (ROC) analysis, [ 68 Ga]Ga-FAPI-04 PET/CT showed better performance in the detection of endoscopic lesions compared with CTE ( P < 0.05). The TBR was significantly associated with the CTE score ( r = 0.81; (95% CI): 0.736–0.869; P < 0.0001) and SES-CD values ( r = 0.86; (95% CI): 0.776–0.908; P < 0.0001). In addition, the global FAPI PET/CT score was significantly correlated with FCP ( r = 0.52; 95% CI, 0.02–0.81; P = 0.039), CRP ( r = 0.60; 95% CI, 0.13–0.85; P = 0.014), CDEIS ( r = 0.55; 95% CI, 0.06–0.83; P = 0.028), and CDAI ( r = 0.81; 95% CI, 0.50–0.93; P < 0.0001). Conclusion In summary, [ 68 Ga]Ga-FAPI-04 PET/CT correlated well with endoscopic, CTE, clinical, and biomarkers of CD. It was also highly sensitive in the detection of different classes of lesions in all intestinal segments, and unlike other examinations, this technique required no patient fasting or bowel preparation. Therefore, [ 68 Ga]Ga-FAPI-04 PET/CT may be a promising method for assessing the activity of CD.