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Research on Prediction Models for Differential Diagnosis of Pancreatic Space-occupying Lesions Based on Multi-parameter Magnetic Resonance Functional Imaging

Research on Prediction Models for Differential Diagnosis of Pancreatic Space-occupying Lesions Based on Multi-parameter Magnetic Resonance Functional Imaging

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500109409
Enrollment
Unknown
Registered
2025-09-17
Start date
2025-09-19
Completion date
Unknown
Last updated
2025-09-22

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

Conditions

Pancreatic space-occupying lesions

Interventions

Index test:The diagnostic model for four-category classification (PDAC, PNET, PCN, inflammatory lesions) of pancreatic space-occupying lesions based on the integration of multi-parameter MRI and clini

Sponsors

The First Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Age between 18-75 years, without gender restriction; 2.Highly suspected pancreatic space-occupying lesions based on clinical assessment, ultrasonography and/or CT preliminary examination; 3.Planning to undergo surgical resection or endoscopic ultrasound-guided fine-needle aspiration biopsy at Southwest Hospital for definitive pathological diagnosis; 4.Able to complete the full MRI scanning sequences required by the study before surgery or biopsy; 5.No contraindications to MRI examination (such as implanted cardiac pacemakers, intracranial metallic foreign bodies, etc.); 6.Having complete clinical data, including basic patient information and laboratory test results (blood amylase, lipase, blood glucose, CA19-9, CEA, etc.); 7.No previous pancreatic-related treatments (surgery, radiotherapy, chemotherapy, interventional therapy, etc.); 8.Patient has normal cognitive function, able to understand and voluntarily sign the informed consent form;

Exclusion criteria

Exclusion criteria: 1.Patients with severe cardiac and pulmonary dysfunction (American College of Cardiology heart function classification grade III or above or NYHA class III or above); 2.Severe liver and kidney dysfunction (Child-Pugh Class C liver dysfunction or eGFR<30ml/min/1.73m^2); 3.Pregnant or lactating women; 4.Patients with severe systemic infection or acute exacerbation of systemic diseases; 5.Patients unable to tolerate 45-minute MRI examination (such as severe claustrophobia); 6.Pancreatic lesions with diameter <1.0cm, difficult for accurate quantitative analysis; 7.Patients with previous pancreatic surgery, pancreatic trauma history, or who have received pancreatic radiotherapy, chemotherapy, or interventional treatment; 8.Patients with active malignant tumors in other systems; 9.Patients who cannot obtain definitive pathological diagnosis for any reason; 10.Patients participating in other clinical studies that may affect the evaluation of this study; 11.Other circumstances deemed unsuitable for participation in this study by the investigator;

Design outcomes

Primary

MeasureTime frame
AUC of the four-classification diagnostic model for pancreatic lesions integrating multi-parameter MRI with clinical indicators;

Secondary

MeasureTime frame
The ability to differentiate between malignant and benign lesions;Sensitivity, specificity and accuracy of the model;

Countries

China

Contacts

Public Contactwei Chen

The First Affiliated Hospital of Army Medical University

landcw@hotmail.com+86 135 0838 3249

Outcome results

None listed

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