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

June 25, 2025 updated by: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Wenbo Li, postgraduate
  • Phone Number: +8615292886778
  • Email: lwb@tmmu.edu.cn

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Recruiting
        • Army Medical Center of PLA, Daping Hospital, Army Medical University
        • Contact:
          • Li
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with IBD according to clinical, imaging, endoscopic, and histopathological criteria.

Description

Inclusion Criteria:

  • 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;
  • Patients voluntarily participate and sign informed consent.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
IBD patient group
Patients diagnosed with IBD according to clinical, imaging, endoscopic, and histopathological criteria.
Diagnostic test: 18F-FAPI PET Imaging
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The efficacy of 18F-FAPI PET imaging and enhanced CT in the identification of intestinal lesions in IBD was compared and evaluated
Time Frame: 2025.4-2027.12
The sensitivity and specificity of PET/ CT and enhanced CT to detect endoscopic lesions were calculated and compared by receiver operating characteristic (ROC) curves.
2025.4-2027.12
Association of 18F-FAPI imaging with endoscopic disease activity
Time Frame: 2025.4-2027.12
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).
2025.4-2027.12
The difference of FAPI SUVmax among different endoscopic MES evaluation groups
Time Frame: 2025.4-2027.12
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.
2025.4-2027.12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

April 10, 2025

First Submitted That Met QC Criteria

April 18, 2025

First Posted (Actual)

April 25, 2025

Study Record Updates

Last Update Posted (Actual)

June 29, 2025

Last Update Submitted That Met QC Criteria

June 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025137

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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