Clinical Value of Deep Learning Reconstruction Technology in Ankle MRI

By enrolling patients who underwent ankle MR(Magnetic Resonance) examinations at our center and using randomized allocation, the patients were divided into a study group and a control group. The study group underwent scanning using AI-based(Artificial Intelligence-based) ankle MRI sequences, while the control group was scanned using non-AI ankle MRI sequences.

Study Overview

• Status: Recruiting
• Conditions: Ankle Trauma

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Lian Yang; Phone Number: 18986273791; Email: yanglian@hust.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Recruiting
      • Union Hospital，Tongji Medical College，Huazhong University of Science and Technology
      • Contact: Lian Yang; Phone Number: 18986273791; Email: yanglian@hust.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

patients with a clear history of ankle trauma

Description

Inclusion Criteria:

1. Patients undergoing ankle MRI at Wuhan Union Hospital from August 2025 to August 2026;
2. Aged > 18 years old;
3. Patients who agree to participate in the study and provide signed informed consent;
4. Presence of a clear history of ankle trauma and related symptoms requiring MRI for diagnosis or evaluation.

Exclusion Criteria:

1 .Patients with MR examination contraindications (e.g., implanted metal devices or severe claustrophobia); 2. Patients with prior ankle surgery; 3. Patients who failed to complete MR examination or whose image quality was insufficient for diagnostic purposes.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
scanning using AI-based ankle MRI sequences
scanned using non-AI ankle MRI sequences

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Patient satisfaction will be evaluated using a Likert scale with the following scoring criteria:5 - Very Satisfied;4 - Satisfied;3 - Neutral;2 - Dissatisfied;1 - Very Dissatisfied.	immediately after procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
total scan time	During procedure
objective image measurements (signal-to-noise ratio)	one week

Collaborators and Investigators

• Sponsor: Lian Yang

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 27, 2025
• First Posted (Actual): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2025-0802

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No