Actively Recruiting

Age: 18Years - 75Years
All Genders
ID06858553

A Prospective, Multi-center Study to Characterize Intestinal Fibrosis in Patients With Crohn's Disease Using MR Enterography-Based Artificial Intelligence

Led by Minhu Chen · Updated on 2025-08-05

234

Participants Needed

5

Research Sites

N/A

Total Duration

On this page

Sponsors

M

Minhu Chen

Lead Sponsor

S

Sixth Affiliated Hospital, Sun Yat-sen University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Intestinal fibrotic strictures are a serious complication affecting over half of patients with Crohn's disease (CD). Despite new medications, effective treatments are limited. Current methods like endoscopy cannot fully assess bowel wall fibrosis, and standardized imaging assessments are lacking. This study aims to develop and validate a deep learning model using magnetic resonance enterography (MRE) to better characterize intestinal fibrosis in CD patients requiring bowel resection. Participants will be recruited from multiple medical centers and divided into groups for training and validating the AI model. The study involves collecting multi-parametric MRI data and surgical specimens, followed by advanced image processing and model development using deep learning techniques. The model will assess fibrosis severity and assist clinical decisions by integrating imaging and molecular data. During the study, researchers will collect detailed patient information, imaging data, and surgical specimens. They will monitor fibrosis and inflammation scores, MRI measurements, and blood tests before and after surgery. Regular quality assurance and data verification procedures ensure accuracy. The study will follow patients from enrollment through surgery and data analysis to support improved diagnosis and treatment planning in Crohn's disease.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients over 18 years old with a confirmed diagnosis of Crohn's disease based on ECCO guidelines
  • Planning to have bowel resection due to stricture in ileum or colon
  • Availability of histological specimens of resected intestinal walls matched with MRE
  • Clear boundaries of the target bowel tract for accurate intestinal segmentation
Not Eligible

You will not qualify if you...

  • Unable to undergo MRI examination
  • Difficult to obtain suitable tissue after surgery
  • Poor quality or artifacts in MRE imaging
  • Target bowel located at anastomosis (anastomotic stricture)
  • Intestinal lesions concurrent with other diseases

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Up to 4 weeks before surgery

Participants undergo MR Enterography (MRE) imaging and clinical assessments before surgery to collect multi-parametric MRI data and clinical measures related to Crohn's disease.

1 to 2 visits before surgery

Surgery and Immediate Post-operative Care

Duration - Surgery day and 1 week after surgery

Participants have bowel resection surgery for intestinal strictures, with collection of histologic specimens of the resected intestinal walls.

1 surgery visit and 1 post-operative visit

Trial Site Locations

Total: 5 locations

1

The First Affiliated Hospital,Sun Yat-sen University

Guangzhou, Guangdong, China, 510080

Actively Recruiting

2

Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Not Yet Recruiting

3

Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University

Nanjing, Jiangsu, China

Not Yet Recruiting

4

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Huangpu, Shanghai Municipality, China

Not Yet Recruiting

5

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Actively Recruiting

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Research Team

M

Minhu Chen, Professor

R

Ren Mao, Professor

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

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.

Xue-Hua Li, Shi-Ting Feng, Qing-Hua Cao...

https://pubmed.ncbi.nlm.nih.gov/33411893

CT-based radiomics signature of visceral adipose tissue for prediction of disease progression in patients with Crohn's disease: A multicentre cohort study.

Xuehua Li, Naiwen Zhang, Cicong Hu...

https://pubmed.ncbi.nlm.nih.gov/36618894

A novel identification system combining diffusion kurtosis imaging with conventional magnetic resonance imaging to assess intestinal strictures in patients with Crohn's disease.

Jin-Fang Du, Bao-Lan Lu, Si-Yun Huang...

https://pubmed.ncbi.nlm.nih.gov/32964274

IVIM with fractional perfusion as a novel biomarker for detecting and grading intestinal fibrosis in Crohn's disease.

Meng-Chen Zhang, Xue-Hua Li, Si-Yun Huang...

https://pubmed.ncbi.nlm.nih.gov/30547200

Real-Time Shear Wave Ultrasound Elastography Differentiates Fibrotic from Inflammatory Strictures in Patients with Crohn's Disease.

Yu-Jun Chen, Ren Mao, Xue-Hua Li...

https://pubmed.ncbi.nlm.nih.gov/29718309

Characterization of Degree of Intestinal Fibrosis in Patients with Crohn Disease by Using Magnetization Transfer MR Imaging.

Xue-Hua Li, Ren Mao, Si-Yun Huang...

https://pubmed.ncbi.nlm.nih.gov/29357272

Intestinal fibrosis classification in patients with Crohn's disease using CT enterography-based deep learning: comparisons with radiomics and radiologists.

Jixin Meng, Zixin Luo, Zhihui Chen...

https://pubmed.ncbi.nlm.nih.gov/35616733