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

NCT06945549 | Recruiting

• 1 other identifier: 2025137
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Inflammatory Bowel Disease (IBD); Disease Activity; FAPI

Keywords

Inflammatory bowel disease; 18F-FAPI PET; disease activity

Outcome Measures

Primary Outcomes (3)

• 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.

  2025.4-2027.12

• 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).

  2025.4-2027.12

• 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.

  2025.4-2027.12

Study Arms (1)

IBD patient group

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

Diagnostic Test: 18F-FAPI PET Imaging

Interventions

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.

IBD patient group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients diagnosed with IBD according to clinical, imaging, endoscopic, and histopathological criteria;
• Patients ≥18 years old;
• F-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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

Related Publications (12)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Gordon IO, Bettenworth D, Bokemeyer A, Srivastava A, Rosty C, de Hertogh G, Robert ME, Valasek MA, Mao R, Li J, Harpaz N, Borralho P, Pai RK, Odze R, Feakins R, Parker CE, Guizzetti L, Nguyen T, Shackelton LM, Sandborn WJ, Jairath V, Baker M, Bruining D, Fletcher JG, Feagan BG, Pai RK, Rieder F; Stenosis Therapy and Anti-Fibrotic Research (STAR) Consortium. International consensus to standardise histopathological scoring for small bowel strictures in Crohn's disease. Gut. 2022 Mar;71(3):479-486. doi: 10.1136/gutjnl-2021-324374. Epub 2021 May 5.

  PMID: 33952604 BACKGROUND

• Wang J, Lin S, Brown JM, van Wagoner D, Fiocchi C, Rieder F. Novel mechanisms and clinical trial endpoints in intestinal fibrosis. Immunol Rev. 2021 Jul;302(1):211-227. doi: 10.1111/imr.12974. Epub 2021 May 16.

  PMID: 33993489 BACKGROUND

• Schmoyer CJ, Saidman J, Bohl JL, Bierly CL, Kuemmerle JF, Bickston SJ. The Pathogenesis and Clinical Management of Stricturing Crohn Disease. Inflamm Bowel Dis. 2021 Oct 20;27(11):1839-1852. doi: 10.1093/ibd/izab038.

  PMID: 33693860 BACKGROUND

• Agrawal M, Spencer EA, Colombel JF, Ungaro RC. Approach to the Management of Recently Diagnosed Inflammatory Bowel Disease Patients: A User's Guide for Adult and Pediatric Gastroenterologists. Gastroenterology. 2021 Jul;161(1):47-65. doi: 10.1053/j.gastro.2021.04.063. Epub 2021 Apr 30.

  PMID: 33940007 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Wenbo Li, postgraduate

CONTACT

+8615292886778; lwb@tmmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 25, 2025
• Study Start: April 25, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 29, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)