Clinical Study of Functional Magnetic Resonance Imaging and Radiomics of Joint Synovial Disease

Sponsor
Peking University Third Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04952896
Collaborator
(none)
100
1
57
1.8

Study Details

Study Description

Brief Summary

Through the high-throughput feature extraction of magnetic resonance images, the radiomics prediction model of joint synovial lesions is constructed to explore whether functional magnetic resonance and radiomics can be used for the diagnosis, differential diagnosis and curative effect monitoring of joint synovial lesions.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Patient Comprehensive Rating Scale

Detailed Description

The study applies functional magnetic resonance and radiomics to the diagnosis of joint synovial lesions, including diffusion weighted imaging (DWI), Intro-Voxel Incoherent Movement (IVIM) and dynamic contrast enhancement Magnetic resonance imaging (DCE-MRI), from the existing conventional magnetic resonance evaluation to multimodal magnetic resonance evaluation, aims to have a more comprehensive understanding of the pathophysiology of the occurrence and development of joint synovial lesions. As a non-invasive imaging method to assess the condition of the disease, radiomics excavates the deep features contained in the image, quantifies the joint synovial lesions, and then gives more information to the clinician in the diagnosis and differential diagnosis of the joint synovial lesions, provide important information for the planning of individualized treatment plans for patients with joint synovial diseases.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Using Functional Magnetic Resonance Imaging and Radiomics Methods to Explore the Auxiliary Diagnosis, Analysis and Clinical Prognosis of Joint Synovial Tissue Lesions.
Actual Study Start Date :
Apr 1, 2019
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Group of patients with good prognosis

Western Ontario and McMaster University Osteoarthritis Index (WOMAC) self-assessment questionnaire scale assesses the frequency of osteoarthritis pain, the severity of pain, body stiffness, and physical dysfunction. The visual analog scale (VAS) is used to evaluate the pain The degree is represented by a total of 11 numbers from 0 to 10 (0 means no pain, 10 means the most painful), and patients are scored according to their own pain levels.

Diagnostic Test: Patient Comprehensive Rating Scale
Patient subjective rating scale

Group of patients with poor prognosis

Western Ontario and McMaster University Osteoarthritis Index (WOMAC) self-assessment questionnaire scale assesses the frequency of osteoarthritis pain, the severity of pain, body stiffness, and physical dysfunction. The visual analog scale (VAS) is used to evaluate the pain The degree is represented by a total of 11 numbers from 0 to 10 (0 means no pain, 10 means the most painful), and patients are scored according to their own pain levels.

Diagnostic Test: Patient Comprehensive Rating Scale
Patient subjective rating scale

Outcome Measures

Primary Outcome Measures

  1. Patient quality of life [2019-2023]

    Patient quality of life

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Inclusion criteria: 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. The patient agreed to receive pre-treatment DCE-MRI, DWI and IVIM scans and imaging omics analysis, had performed or planned to undergo synovial pathological examination (including needle biopsy and postoperative specimen biopsy), agreed to follow-up after treatment, and was able to understand and Complete the postoperative test and sign the informed consent form.
Exclusion Criteria:
  • Exclusion criteria: those who cannot cooperate or refuse to undergo preoperative multimodal magnetic resonance examination; those who have contraindications to MRI scan; those who do not show synovial enhancement changes on MRI scan; the lesion is too small to delineate the area of interest; the pathological diagnosis result is not It belongs to joint synovial disease; patients who have received surgery, medication or other systemic treatment before standardized MRI scan; suffer from kidney disease that requires hemodialysis or peritoneal dialysis; serum creatinine and glomerular filtration rate indicate renal function Insufficiency; a history of tumors in other parts of the joint except for the examination; life-threatening diseases; a history of surgery on the damaged joints in the past 6 months; a history of intramedical injection of hyaluronic acid or steroids in the damaged joints 3 months before the examination, Those who cannot understand and complete the postoperative test correctly.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking University third hospital Beijing Please Select An Option Below China 100089

Sponsors and Collaborators

  • Peking University Third Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking University Third Hospital
ClinicalTrials.gov Identifier:
NCT04952896
Other Study ID Numbers:
  • LM2019168
First Posted:
Jul 7, 2021
Last Update Posted:
Jul 7, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Peking University Third Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 7, 2021