AI-Assisted MRE for Intestinal Fibrosis in Crohn's Disease

NCT06858553 | Recruiting DMC

• 2 other identifiers: No.840[2024]MISP-102507
• Study Type: observational
• Target: 234
• Locations: 1 country
• Sites: 5

Brief Summary

Intestinal fibrotic strictures represent a severe complication of Crohn's disease (CD), affecting over half of the patients. Despite the continuous emergence of novel medications, effective treatment options remain scarce. Endoscopy fails to identify the full-thickness fibrosis of the bowel wall, and standardized assessment for cross-sectional imaging has yet to be established. Previous studies have demonstrated that radiomics models based on computed tomography and deep learning models exhibit commendable diagnostic capability. Thus, this project seeks to conduct a prospective multicenter study, with plans to recruit 234 CD patients requiring bowel resection from five medical centers. The aim is to develop and validate a deep learning model based on magnetic resonance enterography (MRE) to accurately characterize intestinal fibrosis.

Conditions

Crohn Disease (CD)

Keywords

MRE; Artificial Intelligence; Crohn Disease; Fibrosis

Outcome Measures

Primary Outcomes (5)

• histologic inflammation score

  Histologic evaluation of intestinal surgical specimens from enrolled patients was performed using hematoxylin and eosin (H\&E) staining for the histologic inflammation score. The scoring system is graded on a 0-3 scale, with higher scores indicating a greater degree of inflammatory infiltration.

  1 week after surgery

• histologic fibrosis score

  Histologic evaluation of intestinal surgical specimens from enrolled patients was performed using Masson's trichrome staining for the histologic fibrosis score. The scoring system is graded on a 0-3 scale, with higher scores indicating a greater degree of fibrosis severity.

  1 week after surgery

• Magnetization Transfer Ratio

  All enrolled patients underwent Magnetic Resonance Enterography examinations four weeks prior to surgery. Magnetization Transfer Ratio (MTR) is calculated as MTR = \[1 - (Msat / M0)\] × 100, where Msat represents the signal intensity with the magnetization transfer pulse applied, and M0 represents the signal intensity without the MT pulse. To minimize individual variability, MTR is normalized using the skeletal muscle MTR, making it a reliable indicator for assessing intestinal fibrosis.

  4 weeks before surgery

• Apparent Diffusion Coefficient

  All enrolled patients underwent Magnetic Resonance Enterography examinations four weeks prior to surgery. The Apparent Diffusion Coefficient (ADC) is derived from diffusion-weighted imaging (DWI) and measures the movement of water molecules in tissues, indirectly reflecting inflammation and fibrosis severity. Lower ADC values suggest restricted diffusion, which is associated with fibrosis, allowing differentiation between fibrotic and non-fibrotic bowel walls.

  4 weeks before surgery

• Percentage of Enhancement Gain

  All enrolled patients underwent Magnetic Resonance Enterography examinations four weeks prior to surgery. The Percentage of Enhancement Gain is calculated using % Gain = \[(WSI\_7min - WSI\_70s) / WSI\_70s\] × 100, where WSI\_70s and WSI\_7min are the bowel wall signal intensities at 70 seconds and 7 minutes post-contrast injection, respectively. This parameter evaluates hemodynamic changes in the bowel wall, reflecting tissue perfusion characteristics related to inflammation and fibrosis.

  4 weeks before surgery

Secondary Outcomes (7)

• IBD Montreal classification

  2 weeks before surgery

• Crohn's Disease Activity Index

  2 weeks before surgery

• complete blood count

  2 weeks before surgery

• C-reactive protein

  2 weeks before surgery

• procalcitonin

  2 weeks before surgery

Study Arms (2)

training group

This group of patients is used in the training phase of the predictive model to fit an appropriate model.

validation group

This group of patients is used to validate the trained model to determine whether the model has broad applicability.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients from five tertiary-level IBD treatment centers located in different regions of China

You may qualify if:

• Patients Over 18 years old with a confirmed diagnosis of CD based on the criteria of ECCO guideline.
• Planning to receive a bowel resection due to stricture in ileum or colon, and availability of histological specimens of resected intestinal walls matched with MRE are expected to be available.
• Clear boundaries of the target bowel tract enable accurate semi-automatic or fully automatic intestinal segmentation

You may not qualify if:

• Cannot undergo MRI examination
• Difficult to obtain suitable tissue after surgery
• MRE imaging is of poor quality or contains artifacts
• The target bowel is located at the anastomosis (ie, anastomotic stricture)
• Intestinal lesions concurrent with other diseases

Sponsors & Collaborators

• Minhu Chen: lead
• Sixth Affiliated Hospital, Sun Yat-sen University: collaborator
• Sir Run Run Shaw Hospital: collaborator
• Jinling Hospital, China: collaborator
• MSD R&D (China) Co., Ltd.: collaborator
• Ruijin Hospital: collaborator

Study Sites (5)

The First Affiliated Hospital,Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

NOT YET RECRUITING

Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University

Nanjing, Jiangsu, China

NOT YET RECRUITING

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Huangpu, Shanghai Municipality, China

NOT YET RECRUITING

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

Related Publications (12)

• Li XH, Feng ST, Cao QH, Coffey JC, Baker ME, Huang L, Fang ZN, Qiu Y, Lu BL, Chen ZH, Li Y, Bettenworth D, Iacucci M, Sun CH, Ghosh S, Rieder F, Chen MH, Li ZP, Mao R. Degree of Creeping Fat Assessed by Computed Tomography Enterography is Associated with Intestinal Fibrotic Stricture in Patients with Crohn's Disease: A Potentially Novel Mesenteric Creeping Fat Index. J Crohns Colitis. 2021 Jul 5;15(7):1161-1173. doi: 10.1093/ecco-jcc/jjab005.

  PMID: 33411893 BACKGROUND

• Li X, Zhang N, Hu C, Lin Y, Li J, Li Z, Cui E, Shi L, Zhuang X, Li J, Lu J, Wang Y, Liu R, Yuan C, Lin H, He J, Ke D, Tang S, Zou Y, He B, Sun C, Chen M, Huang B, Mao R, Feng ST. CT-based radiomics signature of visceral adipose tissue for prediction of disease progression in patients with Crohn's disease: A multicentre cohort study. EClinicalMedicine. 2022 Dec 30;56:101805. doi: 10.1016/j.eclinm.2022.101805. eCollection 2023 Feb.

  PMID: 36618894 BACKGROUND

• Li Z, Chen Z, Zhang R, et, al. Eur J Nucl Med Mol Imaging. 2024 Feb 15.

  BACKGROUND

• Du JF, Lu BL, Huang SY, Mao R, Zhang ZW, Cao QH, Chen ZH, Li SY, Qin QL, Sun CH, Feng ST, Li ZP, Huang L, Li XH. A novel identification system combining diffusion kurtosis imaging with conventional magnetic resonance imaging to assess intestinal strictures in patients with Crohn's disease. Abdom Radiol (NY). 2021 Mar;46(3):936-947. doi: 10.1007/s00261-020-02765-3. Epub 2020 Sep 22.

  PMID: 32964274 BACKGROUND

• Zhang MC, Li XH, Huang SY, Mao R, Fang ZN, Cao QH, Zhang ZW, Yan X, Chen MH, Li ZP, Sun CH, Feng ST. IVIM with fractional perfusion as a novel biomarker for detecting and grading intestinal fibrosis in Crohn's disease. Eur Radiol. 2019 Jun;29(6):3069-3078. doi: 10.1007/s00330-018-5848-6. Epub 2018 Dec 13.

  PMID: 30547200 BACKGROUND

• Huang SY, Li XH, Huang L, Sun CH, Fang ZN, Zhang MC, Lin JJ, Jiang MJ, Mao R, Li ZP, Zhang Z, Feng ST. T2* Mapping to characterize intestinal fibrosis in crohn's disease. J Magn Reson Imaging. 2018 Apr 17. doi: 10.1002/jmri.26022. Online ahead of print.

  PMID: 29663577 BACKGROUND

• Li Z, Lu B, Lin J, He S, Huang L, Wang Y, Meng J, Li Z, Feng ST, Lin S, Mao R, Li XH. A Type I Collagen-Targeted MR Imaging Probe for Staging Fibrosis in Crohn's Disease. Front Mol Biosci. 2021 Nov 11;8:762355. doi: 10.3389/fmolb.2021.762355. eCollection 2021.

  PMID: 34859052 BACKGROUND

• Li XH, Mao R, Huang SY, Fang ZN, Lu BL, Lin JJ, Xiong SS, Chen MH, Li ZP, Sun CH, Feng ST. Ability of DWI to characterize bowel fibrosis depends on the degree of bowel inflammation. Eur Radiol. 2019 May;29(5):2465-2473. doi: 10.1007/s00330-018-5860-x. Epub 2019 Jan 11.

  PMID: 30635756 BACKGROUND

• Chen YJ, Mao R, Li XH, Cao QH, Chen ZH, Liu BX, Chen SL, Chen BL, He Y, Zeng ZR, Ben-Horin S, Rimola J, Rieder F, Xie XY, Chen MH. Real-Time Shear Wave Ultrasound Elastography Differentiates Fibrotic from Inflammatory Strictures in Patients with Crohn's Disease. Inflamm Bowel Dis. 2018 Sep 15;24(10):2183-2190. doi: 10.1093/ibd/izy115.

  PMID: 29718309 BACKGROUND

• Li XH, Mao R, Huang SY, Sun CH, Cao QH, Fang ZN, Zhang ZW, Huang L, Lin JJ, Chen YJ, Rimola J, Rieder F, Chen MH, Feng ST, Li ZP. Characterization of Degree of Intestinal Fibrosis in Patients with Crohn Disease by Using Magnetization Transfer MR Imaging. Radiology. 2018 May;287(2):494-503. doi: 10.1148/radiol.2017171221. Epub 2018 Jan 19.

  PMID: 29357272 BACKGROUND

• Meng J, Luo Z, Chen Z, Zhou J, Chen Z, Lu B, Zhang M, Wang Y, Yuan C, Shen X, Huang Q, Zhang Z, Ye Z, Cao Q, Zhou Z, Xu Y, Mao R, Chen M, Sun C, Li Z, Feng ST, Meng X, Huang B, Li X. Intestinal fibrosis classification in patients with Crohn's disease using CT enterography-based deep learning: comparisons with radiomics and radiologists. Eur Radiol. 2022 Dec;32(12):8692-8705. doi: 10.1007/s00330-022-08842-z. Epub 2022 May 26.

  PMID: 35616733 BACKGROUND

• Li X, Liang D, Meng J, Zhou J, Chen Z, Huang S, Lu B, Qiu Y, Baker ME, Ye Z, Cao Q, Wang M, Yuan C, Chen Z, Feng S, Zhang Y, Iacucci M, Ghosh S, Rieder F, Sun C, Chen M, Li Z, Mao R, Huang B, Feng ST. Development and Validation of a Novel Computed-Tomography Enterography Radiomic Approach for Characterization of Intestinal Fibrosis in Crohn's Disease. Gastroenterology. 2021 Jun;160(7):2303-2316.e11. doi: 10.1053/j.gastro.2021.02.027. Epub 2021 Feb 17.

  PMID: 33609503 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Surgical bowel specimens from patients with Crohn's disease who underwent surgery due to strictures.

MeSH Terms

Conditions

Crohn Disease; Fibrosis

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Minhu Chen

  First Affiliated Hospital, Sun Yat-Sen University

  STUDY CHAIR

Central Study Contacts

Minhu Chen, Professor

CONTACT

+86 13802957089; chenminhu@mail.sysu.edu.cn

Ren Mao, Professor

CONTACT

+86 13544476809; maor5@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: March 5, 2025
• Study Start: June 3, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: August 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)