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Osteoarthrosis on 7.0T Magnetic Resonance Imaging

Sponsor
Chinese PLA General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05343104
Collaborator
(none)
100
Enrollment
1
Location
38
Anticipated Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This clinical trial studies the use of 7-Tesla (7T)and 3T magnetic resonance imaging (MRI) in detecting osteoarthrosis. 7T MRI has increased detection sensitivity, including more accurate lesion delineation, higher inter-rater agreement. Diagnostic procedures such as 7T MRI may help ultimately improved diagnostic and therapies confidence to inform decision making than standard 3T MRI.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Magnetic resonance imaging

Detailed Description

7T MRI increased detection sensitivity, attain superior anatomic resolution, higher spatial and spectral specificity of advanced quantitative techniques, and shorter scan times than 3T MRI. When applied clinically, these benefits translate to increased detection sensitivity, and ultimately improved diagnostic and therapies confidence to inform decision making. This study aim to detect the image characteristics and diagnostic accuracy of osteoarthrosis on 7T MRI.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Osteoarthrosis on 7.0T Magnetic Resonance Imaging
Actual Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
May 31, 2024
Anticipated Study Completion Date :
May 31, 2025

Outcome Measures

Primary Outcome Measures

  1. The thickness of the cartilage of patellar on 7T MRI scan [baseline]

    Thickness of different part of the cartilage of patellar measured based on axial PD images

  2. The T2 mapping value of the patellar cartilage on 7T MRI scan [baseline]

    T2 relaxation times of the patellar cartilage measured based on T2 mapping

  3. The abnormal signal in the infrapatellar fat pad [baseline]

    The exist of abnormal signal in the infrapatellar fat pad detected based on sagittal PD images

Secondary Outcome Measures

  1. Signal change of the patellar chondral before and after rehabilitation [1 month after rehabilitation]

    The correlation between abnormal change of the patellar chondral and reaction 1 month after rehabilitation

  2. Signal change of the infrapatellar fat pad before and after rehabilitation [1 month after rehabilitation]

    The correlation between abnormal signal in the infrapatellar fat pad and reaction 1 month after rehabilitation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Age≥18 and ≤80

  • Having no contraindications against MRI

  • Clinically stable

Exclusion Criteria:

  • Age#18 or #80

  • Pregnancy and other contraindication to MRI scan

  • Informed consent not obtained

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chinese PLA General Hospital Beijing China 100853

Sponsors and Collaborators

  • Chinese PLA General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xin Lou, Director and Clinical Professor, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT05343104
Other Study ID Numbers:
  • Osteoarthrosis-ChinaPLAGH
First Posted:
Apr 25, 2022
Last Update Posted:
Apr 25, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Xin Lou, Director and Clinical Professor, Chinese PLA General Hospital
MRI
Osteoarthrosis
Additional relevant MeSH terms:
Osteoarthritis

Study Results

No Results Posted as of Apr 25, 2022