Crohn'sRecruiting
AI-Assisted MRE for Intestinal Fibrosis in Crohn's Disease
Observational · No treatment assigned · 5 sites · Minhu Chen
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohn Disease (CD). This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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
There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 234 participants are expected to take part.
- Start date: 2025-06-03.
- Main results expected around 2027-02-28 (estimate from the record).
- 5 study sites listed (2 marked recruiting) in China.
Main thing being measured
- histologic inflammation score (1 week after surgery)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Crohn Disease (CD) |
| Lead sponsor | Minhu Chen |
| Collaborators | Sixth Affiliated Hospital, Sun Yat-sen University; Sir Run Run Shaw Hospital; Jinling Hospital, China; MSD R&D (China) Co., Ltd.; Ruijin Hospital |
| Enrollment | 234 (estimated) |
| Start date | 2025-06-03 |
| Primary completion (est.) | 2027-02-28 |
| First posted | 2025-03-05 |
| Last updated | 2025-08-05 |
| Official title | A Prospective, Multi-center Study to Characterize Intestinal Fibrosis in Patients With Crohn's Disease (CD) Using MR Enterography (MRE)-Based Artificial Intelligence |
| ClinicalTrials.gov ID | NCT06858553 |
Interventions
- None listed
Full eligibility criteria (from the record)
Inclusion Criteria: 1. Patients Over 18 years old with a confirmed diagnosis of CD based on the criteria of ECCO guideline. 2. 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. 3. Clear boundaries of the target bowel tract enable accurate semi-automatic or fully automatic intestinal segmentation Exclusion Criteria: 1. Cannot undergo MRI examination 2. Difficult to obtain suitable tissue after surgery 3. MRE imaging is of poor quality or contains artifacts 4. The target bowel is located at the anastomosis (ie, anastomotic stricture) 5. Intestinal lesions concurrent with other diseases
Locations (5)
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital,Sun Yat-sen University | Guangzhou, Guangdong | 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 |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.