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A prospective, multi-center study to characterize intestinal fibrosis in patients with Crohn’s disease (CD) using MR enterography (MRE)-based artificial intelligence

A prospective, multi-center study to characterize intestinal fibrosis in patients with Crohn’s disease (CD) using MR enterography (MRE)-based artificial intelligence

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500098323
Enrollment
Unknown
Registered
2025-03-06
Start date
2025-04-14
Completion date
Unknown
Last updated
2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's disease

Interventions

Gold Standard:Masson’s trichrome staining of surgical pathology specimens, combined with histological fibrosis scoring, will be used as the gold standard to accurately assess the presence and severity
Index test:A deep learning model based on Magnetic Resonance Enterography (MRE) will be used to characterize the severity of intestinal fibrosis. The MRE parameters included in the analysis comprise M

Sponsors

First Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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 (4) Sign the informed consent form before enrolment.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Pathological score;Magnetic Resonance Enterography;

Secondary

MeasureTime frame
Crohn's Disease Activity Index;IBD Montreal classification;

Countries

China

Contacts

Public ContactMinhu Chen

The First Affiliated Hospital,Sun Yat-sen University

chenminhu@mail.sysu.edu.cn+86 138 0295 7089

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026