NCT06858553Recruiting
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
Source: ClinicalTrials.gov · Last updated 5 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 234 (estimated)
- First submitted
- 19 Feb 2025
- Start date
- 3 Jun 2025
- Primary completion date
- 28 Feb 2027
- Lead sponsor
- Minhu Chen
- Diseases
- Crohn's disease
- NCT number
- NCT06858553
What you commit to
- Study type: Observational
- Planned participants: 234
- From 3 Jun 2025 to the primary completion date, 28 Feb 2027
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Difficult to obtain suitable tissue after surgery
- Intestinal lesions concurrent with other diseases
Other
- Cannot undergo MRI examination
- MRE imaging is of poor quality or contains artifacts
- The target bowel is located at the anastomosis (ie, anastomotic stricture)
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sixth Affiliated Hospital of Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Not yet recruiting |
| The First Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Huangpu | China | Not yet recruiting |
| Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University Coordinator of this site? Confirm its status | Nanjing | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.