Deep Learning of Knee Joint MRI Intelligent Detection

July 8, 2021 updated by: Peking University Third Hospital
Knee joint is the most common part of sports injury. MRI is a powerful tool to diagnose knee joint injury. However, it takes a long time to read the film, needs a lot, and some hidden injuries have a high rate of missed diagnosis. The emerging deep learning technology can establish automatic recognition model through large samples. A large sample of knee joint MRI was collected retrospectively to train the deep learning model of knee joint MRI, and the sensitivity and specificity of the deep learning model were verified in multi center. Depending on the clinical needs, the deep learning model annotation system is established. A large number of knee MRI were obtained and labeled. According to the knee joint MRI training depth learning model, and iterative optimization, the final version is formed. Multi center validation was carried out. Continuous operation records and corresponding preoperative knee MRI were obtained from multiple hospitals. The sensitivity and specificity of the model were calculated with operation records as the gold standard. At the same time, an expert team composed of senior radiologists and sports medicine doctors was organized to read the films. The sensitivity and specificity of manual reading and AI reading were compared to prove the superiority of AI reading. This study can improve the efficiency of clinical MRI film reading, reduce the workload of doctors, improve the film reading level of grass-roots hospitals, promote the development of the discipline, and has good social benefits and market prospects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The knee joint is the most common sports injury site in the human body, including ligament rupture, meniscus tear, cartilage lesions, and free body formation. Knee MRI has extremely high sensitivity and specificity in diagnosing knee diseases, especially its negative predictive value is close to 100%, and it is an effective means to assist clinicians in diagnosing knee diseases. However, there are many MRI sequences of the knee joint, and different diseases have different imaging effects on various sequences, and the types of knee joint diseases are complicated, so it takes a long time to evaluate the knee joint MRI. Due to the huge clinical demand for knee MRI, it has caused a great burden on radiology and sports medicine orthopedics. At the same time, for some special injuries of the knee joint, such as hidden meniscus tear, rupture of the anterior cross part and adhesion in place after rupture, local ligament injury, etc., the conclusions given by different readers are very different, and it is easy to miss the diagnosis. And the missed diagnosis seriously affects the prognosis of the knee joint, leading to the progression of arthritis. In addition, professional musculoskeletal system imaging experts have a long training cycle, and a large number of orthopedic doctors and radiologists in basic hospitals have limited reading skills for knee MRI, which limits the development of local sports medicine disciplines and the development of related diagnosis and treatment. The purpose of our research is to train the deep learning model of knee MRI through multi-center and large sample of knee MRI; Multi-center verification of the sensitivity and specificity of the knee MRI deep learning model, and compare the accuracy of the deep learning model and manual image reading.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Institute of Sports Medicine, Peking University Third Hospital
        • Contact:
          • Ai-Bing Huang, PhD
          • Phone Number: 8615650715003
          • Email: hab165@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients related to sports injuries

Description

Inclusion Criteria:

  1. ACL-injured patients;
  2. Follow-up of patients after ACL injury;
  3. patients with genetic predisposition to ACL injury;

Exclusion Criteria:

  1. Patients with joint injury caused by clear external forces;
  2. Definitely have stroke, heart disease, epilepsy, cranial neurosurgery, migraine;
  3. Have had a concussion or head injury in the past 6 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Marking system design based on Magnetic Resonance Imaging（MRI）
Time Frame: 2021
According to the development goals, combined with the performance of MRI and the structure of the model algorithm, the labeling rules and logic of knee MRI are determined. On this basis, a labeling system is designed, and different labeling tools are designed for a variety of lesions.
2021
Data export and annotation
Time Frame: 2021
Encrypt the MRI file and import it into the medical standard intelligent labeling system. Create a dedicated tagging account for each tagger to tag. Based on the previously marked image data, develop algorithms for segmenting different lesion areas.
2021
Build a deep learning model
Time Frame: 2021
According to the diagnostic logic, we select the coronal and sagittal images of the knee joint T2 MRI sequence for analysis. And choose the Resnext model that has been verified by a large number of ImageNet and other large data sets to extract the features of the coronal out-of-state images. After the multi-layer convolution operation, the key feature representation of the image is extracted. At the same time, in the process of feature extraction, the batch normalization module is used to perform feature transformation to highlight the most meaningful part of the feature.
2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University Third Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chinese PLA General Hospital
Huashan Hospital
Hebei Medical University Third Hospital
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Inner Mongolia People's Hospital
The First Affiliated Hospital of BaoTou Medical College
Fourth Medical Center of PLA General Hospital
The 8th medical center of chinese PLA general hospital
Tianjin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M2020243

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings