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AI-Assisted MRI Differentiation of Inflammatory Demyelinating Diseases

A Multicenter, Observational Study of Deep Learning Models Based on Conventional MRI for the Differential Diagnosis of Inflammatory Demyelinating Diseases

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600129140
Enrollment
Unknown
Registered
2026-07-31
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Inflammatory demyelinating diseases of the central nervous system, including multiple sclerosis (MS), neuromyelitis optica spectrum disorder (NMOSD), and myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD).

Interventions

Gold Standard:1. Upon signing by the principal investigator, this form is deemed to indicate the investigator's commitment that the research project does not involve personal privacy or commercial int
Index test:Brain magnetic resonance imaging

Sponsors

The first affiliated hostipal of nanchang university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Complete conventional MRI examination at the study site, with imaging data available for post-de-identification analysis. 2. Have a definite clinical diagnosis or diagnostic evidence that can serve as background/simulated disease category; diagnosis of MS, NMOSD, and MOGAD should be based on international or domestic diagnostic criteria applicable during the study period and comprehensive clinical judgment. 3. MRI sequence quality meets the minimum requirements for model training, validation, or physician reading evaluation, and at least includes the routine non-contrast MRI sequences required for the study. 4. Necessary clinical data must be obtainable, including diagnosis, examination date, basic information such as age/sex, and data related to model label determination.

Exclusion criteria

Exclusion criteria: 1. Severe artifacts, missing sequences, or format abnormalities in MRI images that prevent standardized preprocessing or image interpretation. 2. Missing key clinical diagnostic information, or diagnosis category cannot be confirmed after investigator review. 3. Repeated examinations cannot confirm independence, or multiple examinations from the same subject do not meet the preset inclusion rules. 4. Other conditions that, in the investigator's judgment, may significantly affect the reliability of imaging labels.

Design outcomes

Primary

MeasureTime frame
AUC, Accuracy, Sensitivity, Specificity, and F1 Score for AI Model Discrimination of MS, NMOSD, MOGAD vs. Similar Diseases in Target Case Identification Task;Overall Accuracy, Class-wise Sensitivity, Specificity, Weighted Average F1 Score, and External Validation Performance of AI Model in Multiclass Differential Diagnosis Task for MS, NMOSD, and MOGAD;

Secondary

MeasureTime frame
Radiologist Read Evaluation: Diagnostic Accuracy, Confidence Scores, Reading Time, and Between-Group Differences Before and After AI Assistance for Junior and Senior Radiologists;Enhanced Prediction Task: AUC, Accuracy, Sensitivity, Specificity, and F1 Score for Predicting Active vs. Non-active Disease Status Based on Non-enhanced MRI;Explainability Metrics: Overlap Rate between SHAP Heatmaps and Expert Diagnostic Rationale, Precision-like Alignment, Recall-like Alignment, and F1-like Alignment;

Countries

China

Contacts

Public ContactWu Lin

The first affiliated hostipal of nanchang university

ndyfy04061@ncu.edu.cn+86 791 88693825

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026