AzTrials
AzTrials

Inflammatory Bowel Disease (IBD)IBD，18F-FAPINCT06945549

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

An observational study of Inflammatory Bowel Disease (IBD) and Disease Activity, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
18F-FAPI PET Imaging
How many people
30 participants
Where
1 siteChina
Study dates
25 Apr 2025to 31 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wenbo Li, postgraduate contact

+8615292886778

lwb@tmmu.edu.cn

China1 site, 1 recruiting

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

    Chongqing, Chongqing Municipality, 400042

    Wenbo Li, +8615292886778, lwb@tmmu.edu.cn

    Li

    Recruiting

Other trials in China

About this study

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

Being tested
18F-FAPI PET Imaging
Keywords
Inflammatory bowel disease, 18F-FAPI PET, disease activity
Medical subject headings
Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 18F-FAPI PET ImagingDiagnostic 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.

Study groups in NCT06945549
Study groupRoleWhat they receive
IBD patient groupPatients diagnosed with IBD according to clinical, imaging, endoscopic, and histopathological criteria.
Receives: Diagnostic Test: 18F-FAPI PET Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2025.4-2027.12

  2. 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).

    Measured: 2025.4-2027.12

  3. 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.

    Measured: 2025.4-2027.12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2025
  2. Study start25 Apr 2025
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06945549
Sponsor's protocol ID
2025137
Acronym
IBD，18F-FAPI
Status last verified
Mar 2025
First submitted
10 Apr 2025
Last updated
29 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 30520951

  • 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.

    PubMed 33952604

  • 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.

    PubMed 33993489

  • 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.

    PubMed 33693860

  • 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.

    PubMed 33940007

Questions about this trial

What is this clinical trial studying?

An observational study of Inflammatory Bowel Disease (IBD) and Disease Activity, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wenbo Li, postgraduate (+8615292886778, lwb@tmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06945549, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in