Multi-Vendor Multi-Site Novel Accelerated MRI Relaxometry
MVMS_MRI
1 other identifier
observational
88
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2020
CompletedFirst Posted
Study publicly available on registry
September 2, 2020
CompletedStudy Start
First participant enrolled
April 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 24, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 28, 2026
ExpectedFebruary 27, 2026
February 1, 2026
3.9 years
August 27, 2020
February 24, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Knee MRI
Knee MRI will be collected at the 3T scanner (Prisma) at CCF. One time point. The MRI exam time will be two hours per subject including set up. No questionnaires will be required.
Year 1-2
Site reproducibility
Knee MRI will be collected at three 3T scanners at CCF (Siemens, GE, Philips), and three scanners at UCSF, University of Kentucky and Albert Einstein College of Medicine, respectively. The three scans at CCF can be on the same day or on different days, but all six scans need to take place within 2 months to minimize potential physiologic variations.To evaluate the reproducibility, subjects will be scanned and then rescanned during one visit on the same day for each of the six scans.
Year 2-3
ACL tear and reconstruction
Knee MRI at three 3T scanners at CCF (Siemens, GE, Philips). For patients, the ACL injured and reconstructed knee will be scanned. For controls, to scan which side of the knee (left or right) will be based on subjects' preference. If the subject has no reference, the dominant leg will be scanned. At each time point, the three scans can be on the same day or on different days, but all the three scans need to take place within 2 weeks to minimize potential physiologic variations. For patients with ACL tear and reconstruction, surgical report (including graft type, surgeon recorded lesions) will also be collected.
Year 3-5
Secondary Outcomes (2)
Site reproducibility with patient outcomes and knee health
Year 2-3
ACL tear and reconstruction with patient outcomes and knee health
Year 3-5
Study Arms (4)
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.
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.
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).
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
Interventions
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.
Eligibility Criteria
Subjects between the ages of 18-50 years old. And subjects who sustain an acute full ACL tear in one knee with the contralateral knee uninjured.
You may qualify if:
- Group 1
- \. Age \> 18
- Group 2
- \. Age 18-50
- Group 3
- Age 18-50
- Sustain an acute full ACL tear in one knee; the contralateral knee uninjured
- Undergo ACL reconstructions and standard rehabilitation
- Group 4
- \. Age 18-50
You may not qualify if:
- Group 1
- Contraindication to MRI such as severe claustrophobia and implanted devices such as neurostimulators, pacemakers, aneurysm clips etc.
- Pregnancy.
- Group 2
- Contraindication to MRI such as severe claustrophobia and implanted devices such as neurostimulators, pacemakers, aneurysm clips etc.
- Pregnancy.
- History of osteoarthritis and inflammatory arthritis
- Previous injury and/or surgery on either knee
- Group 3
- Contraindication to MRI such as severe claustrophobia and implanted devices such as neurostimulators, pacemakers, aneurysm clips etc.
- Pregnancy.
- Inability to undergo standard pre- and post-injury/operative rehabilitation
- Group 4
- Contraindication to MRI such as severe claustrophobia and implanted devices such as neurostimulators, pacemakers, aneurysm clips etc.
- Pregnancy.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xiaojuan Lilead
Study Sites (1)
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaojuan Li
Director, Program for Advanced Musculoskeletal Imaging
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
August 27, 2020
First Posted
September 2, 2020
Study Start
April 1, 2022
Primary Completion
February 24, 2026
Study Completion (Estimated)
December 28, 2026
Last Updated
February 27, 2026
Record last verified: 2026-02