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

Обзор

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

Вмешательства

• Диагностический тест 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.

Первичные конечные точки

• The efficacy of 18F-FAPI PET imaging and enhanced CT in the identification of intestinal lesions in IBD was compared and evaluated [Срок оценки: 2025.4-2027.12]
• Association of 18F-FAPI imaging with endoscopic disease activity [Срок оценки: 2025.4-2027.12]
• The difference of FAPI SUVmax among different endoscopic MES evaluation groups [Срок оценки: 2025.4-2027.12]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Army Medical Center of PLA, Daping Hospital, Army Medical University — Чунцин

Публикации

• 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

Идентификаторы

NCT: NCT06945549 · 2025137

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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