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Crohn Disease (CD)NCT06858553

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

An observational study of Crohn Disease (CD), run by Minhu Chen at 5 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Crohn Disease (CD)
How many people
234 participants
Where
5 sitesChina
Study dates
3 Jun 2025to 28 Feb 2027
How long will I take part?
1 Day
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population consists of patients from five tertiary-level IBD treatment centers located in different regions of China

Who may be able to join

  • 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

Who cannot join

  • Cannot undergo MRI examination
  • Difficult to obtain suitable tissue after surgery
  • MRE imaging is of poor quality or contains artifacts
  • The target bowel is located at the anastomosis (ie, anastomotic stricture)
  • Intestinal lesions concurrent with other diseases

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Minhu Chen, Professor contact

+86 13802957089

chenminhu@mail.sysu.edu.cn

Ren Mao, Professor contact

+86 13544476809

maor5@mail.sysu.edu.cn

5 sites in 1 country

China5 sites, 5 recruiting

  • The First Affiliated Hospital,Sun Yat-sen University

    Guangzhou, Guangdong, 510080

    Minhu Chen, +86 13802957089, chenminhu@mail.sysu.edu.cn

    Pingxin Zhang, Dr.

    Recruiting

  • Sixth Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong

    Xiang Gao, Professor, +86 13502405878, gxiang@sysu.edu.cn

    Not yet recruiting

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    Qian Cao, Professor, +86 13588706896, caoq@srrsh.com

    Recruiting

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Huangpu, Shanghai Municipality

    Duowu Zou, Professor, +86 13901617608, zdwrjxh66@sjtu.edu.cn

    Not yet recruiting

  • Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University

    Nanjing, Jiangsu

    Yi Li, Professor, +86 13851843735, liyi1860@126.com

    Not yet recruiting

Other trials in China

About this study

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

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.

Read the detailed description

Quality Assurance Plan The registry implements a comprehensive quality assurance (QA) plan to validate data and maintain protocol adherence. This includes routine site monitoring, regular audits, and verification of data consistency. Sites participating in the registry are periodically reviewed for compliance with the established operational standards.

Data Entry and Summary Process Management will enforce access regulations to ensure only authorized personnel can enter or query data. Patient information meeting inclusion criteria will be entered into a Tencent form from the hospital's medical record system. Research assistants will supplement this form with details about intestinal surgical specimens, including condition, quantity, and storage, and summarize all specimens. Researchers will summarize the MRE imaging data for the relevant patients. No one may delete, alter, copy, print, or output confidential data without management's consent.

Verification System During patient enrollment, information collection, and specimen collection, two or more research assistants or researchers will confirm the process. Relevant information will be verified again during specimen collection, labeling, and storage. In the analysis phase, researchers will recheck the accuracy of imaging, patient information, and specimens. Management will conduct a random audit every three months to verify patient inclusion criteria and confirm specimen information accuracy.

Data Dictionary A comprehensive data dictionary is used to define each variable collected within the registry. It includes the source of the variable, coding standards and any relevant normal ranges for clinical measures. This data dictionary serves as a reference to ensure uniformity in data collection and analysis.

Standard Operating Procedures (SOPs) The registry follows established Standard Operating Procedures (SOPs) for various registry functions, including patient recruitment, data collection, management, and analysis. SOPs also cover reporting procedures for adverse events, including guidelines for data reporting and event classification. Change management processes are in place to address any amendments or updates to registry protocols.

Sample Size Assessment A statistical sample size calculation has been performed to ensure that the registry is adequately powered to detect meaningful differences or effects. This calculation takes into account the expected incidence of the event of interest, anticipated variability, and the desired statistical power. The required number of participants or participant years is specified based on the primary and secondary objectives of the study.

Plan for Missing Data The registry has a clear policy for handling missing data, including cases where data may be unavailable, uninterpretable, or missing due to inconsistencies (e.g., out-of-range results). A specific protocol is followed for imputing missing values or excluding incomplete data from analysis, ensuring the final dataset remains reliable and valid for statistical analysis.

Statistical Analysis Methods Automatic recognition and segmentation of intestinal lesions in images, based on multi-parametric MRI data and artificial intelligence models, are used to evaluate intestinal fibrosis and assist in clinical decision-making. Specifically, the process includes: performing VOI annotation to generate 3D VOI; normalizing and resampling MRE images, cropping voxel intensity and applying min-max normalization; decomposing each 3D MRE lesion image into patches, and applying 5-fold data augmentation as input to the network; developing a deep learning segmentation algorithm using the nnU-Net model for automatic recognition of intestinal lesion images, with performance evaluated using the Dice similarity coefficient; constructing a ResNet model to accurately assess different degrees of intestinal fibrosis, with output as a predicted probability between 0 and 1; collecting multi-parametric MRI data prior to model construction and extracting features not affected by intestinal inflammation; excluding relevant features during model development, retaining only those reflecting intestinal fibrosis; after model construction, grouping patients based on inflammation severity and re-evaluating the AI model's recognition capability. Through these steps and the integration of multi-omics data, molecular subtyping and related prognostic analysis of patients are achieved to assist in clinical treatment decision-making.

Keywords
MRE, Artificial Intelligence, Crohn Disease, Fibrosis
Medical subject headings
Crohn Disease, Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06858553
Study groupRoleWhat they receive
training groupThis group of patients is used in the training phase of the predictive model to fit an appropriate model.
validation groupThis group of patients is used to validate the trained model to determine whether the model has broad applicability.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. histologic inflammation score

    Histologic evaluation of intestinal surgical specimens from enrolled patients was performed using hematoxylin and eosin (H\&E) staining for the histologic inflammation score. The scoring system is graded on a 0-3 scale, with higher scores indicating a greater degree of inflammatory infiltration.

    Measured: 1 week after surgery

  2. histologic fibrosis score

    Histologic evaluation of intestinal surgical specimens from enrolled patients was performed using Masson's trichrome staining for the histologic fibrosis score. The scoring system is graded on a 0-3 scale, with higher scores indicating a greater degree of fibrosis severity.

    Measured: 1 week after surgery

  3. Magnetization Transfer Ratio

    All enrolled patients underwent Magnetic Resonance Enterography examinations four weeks prior to surgery. Magnetization Transfer Ratio (MTR) is calculated as MTR = [1 - (Msat / M0)] × 100, where Msat represents the signal intensity with the magnetization transfer pulse applied, and M0 represents the signal intensity without the MT pulse. To minimize individual variability, MTR is normalized using the skeletal muscle MTR, making it a reliable indicator for assessing intestinal fibrosis.

    Measured: 4 weeks before surgery

  4. Apparent Diffusion Coefficient

    All enrolled patients underwent Magnetic Resonance Enterography examinations four weeks prior to surgery. The Apparent Diffusion Coefficient (ADC) is derived from diffusion-weighted imaging (DWI) and measures the movement of water molecules in tissues, indirectly reflecting inflammation and fibrosis severity. Lower ADC values suggest restricted diffusion, which is associated with fibrosis, allowing differentiation between fibrotic and non-fibrotic bowel walls.

    Measured: 4 weeks before surgery

  5. Percentage of Enhancement Gain

    All enrolled patients underwent Magnetic Resonance Enterography examinations four weeks prior to surgery. The Percentage of Enhancement Gain is calculated using % Gain = [(WSI_7min - WSI_70s) / WSI_70s] × 100, where WSI_70s and WSI_7min are the bowel wall signal intensities at 70 seconds and 7 minutes post-contrast injection, respectively. This parameter evaluates hemodynamic changes in the bowel wall, reflecting tissue perfusion characteristics related to inflammation and fibrosis.

    Measured: 4 weeks before surgery

Secondary outcomes (7)

  1. IBD Montreal classification

    The Montreal classification of Crohn's disease includes three main categories: age, disease location, and disease behavior. Age (A) is classified as ≤16 years (A1), 17-40 years (A2), and ≥40 years (A3). Disease location (L) is categorized into terminal ileum (L1), colon (L2), ileocolon (L3), and upper gastrointestinal tract (L4). Disease behavior (B) is classified as non-stricturing, non-penetrating (B1), stricturing (B2), and penetrating (B3). Additionally, perianal fistulizing disease (P) can occur in association with any of the disease behavior subtypes.

    Measured: 2 weeks before surgery

  2. Crohn's Disease Activity Index

    The Crohn's Disease Activity Index (CDAI) ranges from a minimum of 0 with no fixed maximum value. When using CDAI to assess disease status, different score thresholds are commonly applied: CDAI <150 indicates remission, while CDAI ≥150 indicates active disease. Within the active disease category, 150-220 is classified as mild activity, 221-450 as moderate activity, and >450 as severe activity.

    Measured: 2 weeks before surgery

  3. complete blood count

    Calculate the quantity and percentage of each category of serum cells.

    Measured: 2 weeks before surgery

  4. C-reactive protein

    Measure the concentration of serum C-reactive protein, expressed in mg/L.

    Measured: 2 weeks before surgery

  5. procalcitonin

    Measure the concentration of serum procalcitonin, expressed in ng/mL.

    Measured: 2 weeks before surgery

  6. erythrocyte sedimentation rate

    Measure the erythrocyte sedimentation rate of the blood，expressed in mm/h.

    Measured: 2 weeks before surgery

  7. serum albumin

    Measure the level of serum albumin, expressed in g/L.

    Measured: 2 weeks before surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2025
  2. Study start3 Jun 2025
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion28 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
234 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT06858553
Sponsor's protocol ID
No.840[2024]
Other IDs
MISP-102507
Status last verified
Aug 2025
First submitted
19 Feb 2025
Last updated
5 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: In this study, we do not intend to publicly release raw patient data for the following reasons: 1. Patient Privacy Protection: Raw data may include sensitive personal information, such as names and medical history. Public release could expose this information, violating patient privacy rights and privacy regulations. 2. Data Security: The raw data includes medical images and clinical information, which could be misused if released. Access will be restricted to the research team to ensure data security. 3. Ethical Considerations: Informed consent was obtained from patients with clear terms regarding data usage. They did not consent to public release of raw data, and doing so could breach the original agreement. 4. De-identification: While de-identified data may be used, raw data that could identify patients will not be released to protect their privacy. 5. Prevention of Data Misuse: Releasing raw data could lead to misuse by unauthorized parties.

Publications

  • Li XH, Feng ST, Cao QH, Coffey JC, Baker ME, Huang L, Fang ZN, Qiu Y, Lu BL, Chen ZH, Li Y, Bettenworth D, Iacucci M, Sun CH, Ghosh S, Rieder F, Chen MH, Li ZP, Mao R. 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. J Crohns Colitis. 2021 Jul 5;15(7):1161-1173. doi: 10.1093/ecco-jcc/jjab005.

    PubMed 33411893

  • Li X, Zhang N, Hu C, Lin Y, Li J, Li Z, Cui E, Shi L, Zhuang X, Li J, Lu J, Wang Y, Liu R, Yuan C, Lin H, He J, Ke D, Tang S, Zou Y, He B, Sun C, Chen M, Huang B, Mao R, Feng ST. CT-based radiomics signature of visceral adipose tissue for prediction of disease progression in patients with Crohn's disease: A multicentre cohort study. EClinicalMedicine. 2022 Dec 30;56:101805. doi: 10.1016/j.eclinm.2022.101805. eCollection 2023 Feb.

    PubMed 36618894

  • Li Z, Chen Z, Zhang R, et, al. Eur J Nucl Med Mol Imaging. 2024 Feb 15.

  • Du JF, Lu BL, Huang SY, Mao R, Zhang ZW, Cao QH, Chen ZH, Li SY, Qin QL, Sun CH, Feng ST, Li ZP, Huang L, Li XH. A novel identification system combining diffusion kurtosis imaging with conventional magnetic resonance imaging to assess intestinal strictures in patients with Crohn's disease. Abdom Radiol (NY). 2021 Mar;46(3):936-947. doi: 10.1007/s00261-020-02765-3. Epub 2020 Sep 22.

    PubMed 32964274

  • Zhang MC, Li XH, Huang SY, Mao R, Fang ZN, Cao QH, Zhang ZW, Yan X, Chen MH, Li ZP, Sun CH, Feng ST. IVIM with fractional perfusion as a novel biomarker for detecting and grading intestinal fibrosis in Crohn's disease. Eur Radiol. 2019 Jun;29(6):3069-3078. doi: 10.1007/s00330-018-5848-6. Epub 2018 Dec 13.

    PubMed 30547200

  • Huang SY, Li XH, Huang L, Sun CH, Fang ZN, Zhang MC, Lin JJ, Jiang MJ, Mao R, Li ZP, Zhang Z, Feng ST. T2* Mapping to characterize intestinal fibrosis in crohn's disease. J Magn Reson Imaging. 2018 Apr 17. doi: 10.1002/jmri.26022. Online ahead of print.

    PubMed 29663577

  • Li Z, Lu B, Lin J, He S, Huang L, Wang Y, Meng J, Li Z, Feng ST, Lin S, Mao R, Li XH. A Type I Collagen-Targeted MR Imaging Probe for Staging Fibrosis in Crohn's Disease. Front Mol Biosci. 2021 Nov 11;8:762355. doi: 10.3389/fmolb.2021.762355. eCollection 2021.

    PubMed 34859052

  • Li XH, Mao R, Huang SY, Fang ZN, Lu BL, Lin JJ, Xiong SS, Chen MH, Li ZP, Sun CH, Feng ST. Ability of DWI to characterize bowel fibrosis depends on the degree of bowel inflammation. Eur Radiol. 2019 May;29(5):2465-2473. doi: 10.1007/s00330-018-5860-x. Epub 2019 Jan 11.

    PubMed 30635756

  • Chen YJ, Mao R, Li XH, Cao QH, Chen ZH, Liu BX, Chen SL, Chen BL, He Y, Zeng ZR, Ben-Horin S, Rimola J, Rieder F, Xie XY, Chen MH. Real-Time Shear Wave Ultrasound Elastography Differentiates Fibrotic from Inflammatory Strictures in Patients with Crohn's Disease. Inflamm Bowel Dis. 2018 Sep 15;24(10):2183-2190. doi: 10.1093/ibd/izy115.

    PubMed 29718309

  • Li XH, Mao R, Huang SY, Sun CH, Cao QH, Fang ZN, Zhang ZW, Huang L, Lin JJ, Chen YJ, Rimola J, Rieder F, Chen MH, Feng ST, Li ZP. Characterization of Degree of Intestinal Fibrosis in Patients with Crohn Disease by Using Magnetization Transfer MR Imaging. Radiology. 2018 May;287(2):494-503. doi: 10.1148/radiol.2017171221. Epub 2018 Jan 19.

    PubMed 29357272

  • Meng J, Luo Z, Chen Z, Zhou J, Chen Z, Lu B, Zhang M, Wang Y, Yuan C, Shen X, Huang Q, Zhang Z, Ye Z, Cao Q, Zhou Z, Xu Y, Mao R, Chen M, Sun C, Li Z, Feng ST, Meng X, Huang B, Li X. Intestinal fibrosis classification in patients with Crohn's disease using CT enterography-based deep learning: comparisons with radiomics and radiologists. Eur Radiol. 2022 Dec;32(12):8692-8705. doi: 10.1007/s00330-022-08842-z. Epub 2022 May 26.

    PubMed 35616733

  • Li X, Liang D, Meng J, Zhou J, Chen Z, Huang S, Lu B, Qiu Y, Baker ME, Ye Z, Cao Q, Wang M, Yuan C, Chen Z, Feng S, Zhang Y, Iacucci M, Ghosh S, Rieder F, Sun C, Chen M, Li Z, Mao R, Huang B, Feng ST. Development and Validation of a Novel Computed-Tomography Enterography Radiomic Approach for Characterization of Intestinal Fibrosis in Crohn's Disease. Gastroenterology. 2021 Jun;160(7):2303-2316.e11. doi: 10.1053/j.gastro.2021.02.027. Epub 2021 Feb 17.

    PubMed 33609503

Questions about this trial

What is this clinical trial studying?

An observational study of Crohn Disease (CD), run by Minhu Chen at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Minhu Chen, Professor (+86 13802957089, chenminhu@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

histologic inflammation score (time frame: 1 week after surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06858553, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.

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