Multi-Vendor Multi-Site Novel Accelerated MRI Relaxometry

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Xiaojuan Li
Study ID
NCT04536103
Status
Recruiting
Apply to this trial

Conditions

  • ACL Tear
  • Bone Diseases, Infectious
  • Cartilage Degeneration
  • Joint Diseases
  • Musculoskeletal Diseases
  • Osteoarthritis

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • MRI — DIAGNOSTIC_TEST
    Observational Study of novel MR imaging and image processing techniques that will provide reliable and fully quantitative evaluation of inflammation, chronic structural changes and vascularity in healthy patients and patients with ACL injury.

Study Details

Currently the diagnosis of OA is based on radiographs and clinical findings, which is limited to detecting late-stage disease. There is a pressing, unmet clinical need for robust assessment of early changes in cartilage health. Towards this goal, extensive efforts are ongoing to develop quantitative MRI for cartilage matrix analysis. MR T1ρ and T2 relaxation times have shown to be promising imaging biomarkers for early cartilage degeneration and prediction of disease progression. However, many challenges remain to clinically applying these techniques, including lack of standardized acquisition and quantification methods, and long acquisition times. The study aims to develop novel, fast and reproducible MR T1ρ and T2 relaxation time imaging methods on MR systems from multiple vendors and establish a platform for standardization and cross validation of these measures as a tool for clinical trials using such techniques. Following method validation, patients at risk for osteoarthritis will be tested.

Key Dates

Start date
Apr 1, 2022
Status verified
Feb 2026
Primary completion
Feb 24, 2026
Completion
Dec 28, 2026

Study Design

Enrollment
88 participants (estimated)

Arms

  • Arm: Cleveland Clinic Foundation (CCF) Volunteers
    The group will be used for evaluating differences between standard T1rho and T2 imaging vs accelerated T1rho and T2 imaging techniques that will be developed from this study.
  • Arm: Traveling Volunteers
    The group will be recruited at CCF and be scanned at CCF, University of California San Francisco, University of Kentucky and Albert Einstein College of Medicine.
  • Arm: ACL tear Volunteers
    This group will be recruited at CCF and scanned at baseline and 1-year at all of the three MR systems at CCF (Siemens, GE, Philips).
  • Arm: Group Matched to ACL tear Volunteers
    This group will be recruited at CCF and scanned at baseline and 1-year at all of the three MR systems at CCF (Siemens, GE, Philips).Traveling Volunteers share the same inclusion and exclusion criteria as this group, therefore subjects can participate the study and serve as subjects within both groups

Primary Outcome Measure

Knee MRI [ Time Frame: Year 1-2 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic FoundationClevelandOhio44195
Xiaojuan Li, PhD
[email protected]
510-685-3495

Find similar trials in Cleveland, OH

By condition
Osteoarthritis (other)
By specialty
OrthopedicsMusculoskeletal disorders
By research site
Cleveland Clinic Foundation· Cleveland, OH

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