Clinical Value of Deep Learning Reconstruction Technology... | NCT07274423

Studies
Clinical Value of Deep Learning Reconstruction Technology in Ankle MRI

NCT07274423

Sponsor

Lian Yang

Status

Recruiting

Last Update Posted

Dec 10, 2025Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Ankle Trauma

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2025Actual

Primary Completion Date

Aug 1, 2026Estimated

Completion Date

Aug 1, 2026Estimated

First Submitted Date

Nov 19, 2025

First Submission Date that Met QC Criteria

Nov 27, 2025

First Posted Date

Dec 10, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 27, 2025

Last Update Posted Date

Dec 10, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lian Yang, Director, Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologySponsor-Investigator

Lead Sponsor

Lian YangOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing ankle MRI at Wuhan Union Hospital from August 2025 to August 2026;
Aged > 18 years old;
Patients who agree to participate in the study and provide signed informed consent;
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with a clear history of ankle trauma

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lian Yang	Contact	18986273791		yanglian@hust.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Union Hospital，Tongji Medical College，Huazhong University of Science and Technology	Recruiting	Wuhan	Hubei	430000	China

Label	Type	Description	Intervention Names
scanning using AI-based ankle MRI sequences
scanned using non-AI ankle MRI sequences