Evaluation of Intestinal Lesions and Disease Activity in Inflammatory Bowel Disease Based on 18F-FAPI PET Imaging

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 18F-FAPI PET Imaging

    Diagnostic test

    The 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

30 Participants
are divided into 1 treatment group
Group A: IBD patient group1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
2025.4-2027.12
2

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).

Time frame
2025.4-2027.12
3

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.

Time frame
2025.4-2027.12

Secondary outcomes

Other outcomes

Sponsors and contacts

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