A Prospective, Multi-center Study to Characterize Intestinal Fibrosis in Patients With Crohn's Disease (CD) Using MR Enterography (MRE)-Based Artificial Intelligence
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 234
- 试验地点
- 5
- 主要终点
- histologic inflammation score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
histologic inflammation score
时间窗: 1 week after surgery
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.
histologic fibrosis score
时间窗: 1 week after surgery
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.
Magnetization Transfer Ratio
时间窗: 4 weeks before surgery
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.
Apparent Diffusion Coefficient
时间窗: 4 weeks before surgery
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.
Percentage of Enhancement Gain
时间窗: 4 weeks before surgery
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.
次要结局
- IBD Montreal classification(2 weeks before surgery)
- Crohn's Disease Activity Index(2 weeks before surgery)
- complete blood count(2 weeks before surgery)
- C-reactive protein(2 weeks before surgery)
- procalcitonin(2 weeks before surgery)
- erythrocyte sedimentation rate(2 weeks before surgery)
- serum albumin(2 weeks before surgery)
研究者
Minhu Chen
Professor
First Affiliated Hospital, Sun Yat-Sen University