NCT04952896

Brief Summary

Through the high-throughput feature extraction of magnetic resonance images, the deep learning prediction model of joint synovial lesions is constructed used for the diagnosis, differential diagnosis and curative effect monitoring of joint synovial lesions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
9.5 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 7, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2022

Completed
Last Updated

November 2, 2022

Status Verified

May 1, 2022

Enrollment Period

10.3 years

First QC Date

June 29, 2021

Last Update Submit

October 29, 2022

Conditions

Keywords

pigmented villonodular synovitisdeep learningknee synovitisMRI

Outcome Measures

Primary Outcomes (1)

  • Patient's diagnosis

    Type of synovitis disease in patients with a clear comprehensive diagnosis

    2019-2022

Study Arms (3)

Group of patients with pigmented villonodular synovitis

Diagnosis confirmed by arthroscopic pathological biopsy.

Diagnostic Test: Synovitis diagnosis

Group of patients with rheumatoid arthritis

Diagnosis determined by clinical history, laboratory tests and arthroscopic pathology biopsy.

Diagnostic Test: Synovitis diagnosis

Group of patients with gout

Diagnosis was determined by laboratory tests, energy spectrum imaging and arthroscopic pathology biopsy.

Diagnostic Test: Synovitis diagnosis

Interventions

Synovitis diagnosisDIAGNOSTIC_TEST
Group of patients with goutGroup of patients with pigmented villonodular synovitisGroup of patients with rheumatoid arthritis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with joint synovial disease through radiological examination, arthroscopy or pathological biopsy of the joint, or whose clinical manifestations meet the diagnostic criteria of the American College of Rheumatology (ACR) for joint synovial disease.

You may qualify if:

  • Patients diagnosed with joint synovial disease through radiological examination, arthroscopy or pathological biopsy of the joint, or whose clinical manifestations meet the diagnostic criteria of the American College of Rheumatology (ACR) for joint synovial disease.
  • Patients received pre-treatment MR.

You may not qualify if:

  • Patients who have received surgery, medication or other systemic treatment before standardized MRI scan.
  • Poor image quality.
  • Articular hemorrhage.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University third hospital

Beijing, Please Select An Option Below, 100089, China

Location

MeSH Terms

Conditions

Synovitis, Pigmented VillonodularGoutArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Giant Cell Tumor of Tendon SheathGiant Cell TumorsNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsSynovitisJoint DiseasesMusculoskeletal DiseasesTendinopathyMuscular DiseasesArthritisCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2021

First Posted

July 7, 2021

Study Start

January 1, 2012

Primary Completion

March 31, 2022

Study Completion

October 29, 2022

Last Updated

November 2, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ANALYTIC CODE

Locations