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NCT Number: NCT06945549

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

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

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Key information

Conditions

Inflammatory Bowel Disease (IBD) Digestive System Diseases Disease Activity FAPI Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Army Medical Center of PLA, Daping Hospital, Army Medical University

Chongqing, Chongqing Municipality, 400042, China

Location status: Recruiting

Location contact

Li

CONTACT

Wenbo Li

CONTACT

[email protected]

+8615292886778

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

    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.

  2. 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).

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Wenbo Li, postgraduate

CONTACT

[email protected]

+8615292886778

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: IBD，18F-FAPI

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 25, 2025
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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