About this trial
The goal of this observational study is to evaluate the role and effect of 18F-FAPI PET imaging in the identification of intestinal lesions and the assessment of disease activity in inflammatory bowel disease. The main question it aims to answer is:
Can 18F-FAPI PET imaging effectively identify intestinal lesions in inflammatory bowel disease and accurately assess disease activity? Colonoscopy, enhanced abdominal CT, and 18F-FAPI intestinal imaging were completed within 1 week, and major adverse outcomes (MAO) were followed up 12 months after enrollment.
Last updated on March 25, 2025
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients diagnosed with IBD according to clinical, imaging, endoscopic, and histopathological criteria;
Patients ≥18 years old;
18F-FAPI PET/CT intestinal imaging, conventional endoscopic and enhanced CT were performed within 1 week;
Intestinal segment matching was evaluated by endoscopy and imaging;
Disqualifiers
Pregnant or lactating patients;
Imaging images are of poor quality and cannot be used for diagnosis and evaluation;
Patients with contraindications for endoscopic or CT examination.
Trial population
Patients diagnosed with IBD according to clinical, imaging, endoscopic, and histopathological criteria.
Trial design
Cohort
Prospective
Treatments tested in this trial
18F-FAPI PET Imaging
Diagnostic testThe ROI of the target lesions was delineated based on 18F-FAPI PET Imaging, and the lesions were divided on the cross section to obtain the lesions SUVmax, SUVmean, SUVpeak, FAPI metabolic volume (FAV), MTV, TBR, and TLG.
Treatment groups
Trial outcomes
Primary outcomes
The efficacy of 18F-FAPI PET imaging and enhanced CT in the identification of intestinal lesions in IBD was compared and evaluated
The sensitivity and specificity of PET/ CT and enhanced CT to detect endoscopic lesions were calculated and compared by receiver operating characteristic (ROC) curves.
Association of 18F-FAPI imaging with endoscopic disease activity
Spearman test was used to evaluate the correlation between overall FAPI PET/CT score and IBD endoscopic range of motion (modified Mayo endoscopic score, UCEIS).
The difference of FAPI SUVmax among different endoscopic MES evaluation groups
Taking into account multiple intestinal segments in each patient, mixed model ANOVA and Bonferroni-adjusted postmortem tests were performed to compare the differences in SUVmax between different MES rating groups.
Sponsors and contacts
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