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Recruiting NCT06945549

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

— Observational Inflammatory Bowel Disease (IBD) Disease Activity FAPI

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 18F-FAPI PET Imaging.
Who it may be relevant to
Registry conditions: Inflammatory Bowel Disease (IBD), Disease Activity, FAPI. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • 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.

Primary outcome measures

  • 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]
  • Association of 18F-FAPI imaging with endoscopic disease activity [Time frame: 2025.4-2027.12]
  • The difference of FAPI SUVmax among different endoscopic MES evaluation groups [Time frame: 2025.4-2027.12]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Army Medical Center of PLA, Daping Hospital, Army Medical University — Chongqing

Publications

  • Luo Y, Pan Q, Xu H, Zhang R, Li J, Li F. Active uptake of 68Ga-FAPI in Crohn's disease but not in ulcerative colitis. Eur J Nucl Med Mol Imaging. 2021 May;48(5):1682-1683. doi: 10.1007/s00259-020-05129-7. Epub 2020 Nov 27. No abstract available. PMID 33247327
  • Chen L, Zhong X, Li L, Li X, Liu Y, Guo C, Chen Y, Huang Z. [68Ga]Ga-FAPI-04 PET/CT on assessing Crohn's disease intestinal lesions. Eur J Nucl Med Mol Imaging. 2023 Apr;50(5):1360-1370. doi: 10.1007/s00259-023-06107-5. Epub 2023 Jan 12. PMID 36631715
  • Luo Y, Pan Q, Yang H, Peng L, Zhang W, Li F. Fibroblast Activation Protein-Targeted PET/CT with 68Ga-FAPI for Imaging IgG4-Related Disease: Comparison to 18F-FDG PET/CT. J Nucl Med. 2021 Feb;62(2):266-271. doi: 10.2967/jnumed.120.244723. Epub 2020 Jun 8. PMID 32513902
  • Diekmann J, Koenig T, Thackeray JT, Derlin T, Czerner C, Neuser J, Ross TL, Schafer A, Tillmanns J, Bauersachs J, Bengel FM. Cardiac Fibroblast Activation in Patients Early After Acute Myocardial Infarction: Integration with MR Tissue Characterization and Subsequent Functional Outcome. J Nucl Med. 2022 Sep;63(9):1415-1423. doi: 10.2967/jnumed.121.263555. Epub 2022 Feb 24. PMID 35210301
  • Pang Y, Zhao L, Luo Z, Hao B, Wu H, Lin Q, Sun L, Chen H. Comparison of 68Ga-FAPI and 18F-FDG Uptake in Gastric, Duodenal, and Colorectal Cancers. Radiology. 2021 Feb;298(2):393-402. doi: 10.1148/radiol.2020203275. Epub 2020 Dec 1. PMID 33258746
  • Jacobson FL, Van den Abbeele AD. Importance of 68Ga-FAPI PET/CT for Detection of Cancer. Radiology. 2022 Apr;303(1):200-201. doi: 10.1148/radiol.212884. Epub 2022 Jan 4. No abstract available. PMID 34981981
  • Scharl M, Huber N, Lang S, Furst A, Jehle E, Rogler G. Hallmarks of epithelial to mesenchymal transition are detectable in Crohn's disease associated intestinal fibrosis. Clin Transl Med. 2015 Feb 7;4:1. doi: 10.1186/s40169-015-0046-5. eCollection 2015. PMID 25852817
  • Lovisa S, Genovese G, Danese S. Role of Epithelial-to-Mesenchymal Transition in Inflammatory Bowel Disease. J Crohns Colitis. 2019 Apr 26;13(5):659-668. doi: 10.1093/ecco-jcc/jjy201. PMID 30520951

Identifiers

NCT: NCT06945549 · 2025137

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗