RecruitingNCT06858553

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

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


Sponsor

Minhu Chen

Enrollment

234 participants

Start Date

Jun 3, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is developing an AI-assisted MRI technique (called MR elastography or MRE) to detect intestinal fibrosis — the buildup of scar tissue in the bowel — in patients with Crohn's disease who are undergoing bowel surgery. Better imaging could help doctors make more accurate decisions before and after surgery. **You may be eligible if...** - You are over 18 with a confirmed diagnosis of Crohn's disease - You are scheduled for bowel resection surgery due to a stricture (narrowing) in the small or large intestine - The target bowel section can be clearly identified and imaged **You may NOT be eligible if...** - You cannot have an MRI scan (e.g., due to a metal implant) - Sufficient tissue samples cannot be obtained after surgery - Your MRI images are poor quality or have too many artifacts - The narrowing is located at a surgical connection site (anastomosis) - You have another disease affecting the bowel lesion Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(5)

The First Affiliated Hospital,Sun Yat-sen University

Guangzhou, Guangdong, China

Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University

Nanjing, Jiangsu, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Huangpu, Shanghai Municipality, China

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT06858553


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