Multi-Vendor Multi-Site Novel Accelerated MRI Relaxometry (MVMS_MRI)
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ClinicalTrials.gov Identifier: NCT04536103 |
Recruitment Status :
Recruiting
First Posted : September 2, 2020
Last Update Posted : October 20, 2022
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Condition or disease | Intervention/treatment |
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Bone Diseases, Infectious Musculoskeletal Diseases Joint Diseases Osteoarthritis ACL Tear Cartilage Degeneration | Diagnostic Test: MRI |

Study Type : | Observational |
Estimated Enrollment : | 88 participants |
Observational Model: | Other |
Time Perspective: | Prospective |
Official Title: | Multi-Vendor Multi-Site Novel Accelerated MRI Relaxometry |
Actual Study Start Date : | April 1, 2022 |
Estimated Primary Completion Date : | February 10, 2026 |
Estimated Study Completion Date : | December 28, 2026 |
Group/Cohort | Intervention/treatment |
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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.
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Diagnostic Test: MRI
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. |
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.
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Diagnostic Test: MRI
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. |
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).
|
Diagnostic Test: MRI
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. |
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
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Diagnostic Test: MRI
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. |
- Knee MRI [ Time Frame: Year 1-2 ]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.
- Site reproducibility [ Time Frame: Year 2-3 ]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.
- ACL tear and reconstruction [ Time Frame: Year 3-5 ]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.
- Site reproducibility with patient outcomes and knee health [ Time Frame: Year 2-3 ]Questionnaires of patient reported outcomes (PROMs) including KOOS, IKDC, Marx, SF-36 will be collected at CCF for one time, which will take approximately 30-60 minutes
- ACL tear and reconstruction with patient outcomes and knee health [ Time Frame: Year 3-5 ]Questionnaires of patient reported outcomes (PROMs) including KOOS, IKDC, Marx, SF-36 will be collected at CCF for baseline and 1-year

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Sampling Method: | Probability Sample |
Inclusion Criteria:
Group 1
1. Age > 18
Group 2
1. 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
1. Age 18-50
Exclusion Criteria:
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.
- History of osteoarthritis and inflammatory arthritis
- Previous injury and/or surgery on either knee

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04536103
Contact: Xiaojuan Li, PhD | 510-685-3495 | lix6@ccf.org | |
Contact: Jennifer Baldwin | 216 390-5833 | baldwij3@ccf.org |
United States, Ohio | |
Cleveland Clinic Foundation | Recruiting |
Cleveland, Ohio, United States, 44195 | |
Contact: Xiaojuan Li, PhD 510-685-3495 lix6@ccf.org |
Principal Investigator: | Xiaojuan Li | Director, Program for Advanced Musculoskeletal Imaging |
Responsible Party: | Xiaojuan Li, PI, The Cleveland Clinic |
ClinicalTrials.gov Identifier: | NCT04536103 |
Other Study ID Numbers: |
20-599 |
First Posted: | September 2, 2020 Key Record Dates |
Last Update Posted: | October 20, 2022 |
Last Verified: | October 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Communicable Diseases Infections Bone Diseases, Infectious Joint Diseases |
Bone Diseases Musculoskeletal Diseases Disease Attributes Pathologic Processes |