Recruiting

MRI Relaxometry

Sponsor:

Xiaojuan Li

Code:

NCT04536103

Conditions

Bone Diseases, Infectious

Musculoskeletal Diseases

Joint Diseases

Osteoarthritis

ACL Tear

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

MRI

Study Details

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.

Conditions

Bone Diseases, Infectious

Musculoskeletal Diseases

Joint Diseases

Osteoarthritis

ACL Tear

Study ID

NCT04536103

Start date

Apr 1, 2022

Status verified date

Feb, 2026

Completion date

Dec 28, 2026

Anticipated

Primary completion date

Feb 24, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Inclusion Criteria:

Group 1

1\. Age > 18

Group 2

1\. Age 18-50

Group 3

1. Age 18-50
2. Sustain an acute full ACL tear in one knee; the contralateral knee uninjured
3. Undergo ACL reconstructions and standard rehabilitation

Group 4

1\. Age 18-50

Exclusion Criteria:

Group 1

1. Contraindication to MRI such as severe claustrophobia and implanted devices such as neurostimulators, pacemakers, aneurysm clips etc.
2. Pregnancy.

Group 2

1. Contraindication to MRI such as severe claustrophobia and implanted devices such as neurostimulators, pacemakers, aneurysm clips etc.
2. Pregnancy.
3. History of osteoarthritis and inflammatory arthritis
4. Previous injury and/or surgery on either knee

Group 3

1. Contraindication to MRI such as severe claustrophobia and implanted devices such as neurostimulators, pacemakers, aneurysm clips etc.
2. Pregnancy.
3. Inability to undergo standard pre- and post-injury/operative rehabilitation

Group 4

1. Contraindication to MRI such as severe claustrophobia and implanted devices such as neurostimulators, pacemakers, aneurysm clips etc.
2. Pregnancy.
3. History of osteoarthritis and inflammatory arthritis
4. Previous injury and/or surgery on either knee

Study Design

Enrollment

88 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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.

Primary outcome measure

  • Knee MRI [ Time Frame: Year 1-2 ]
  • Site reproducibility [ Time Frame: Year 2-3 ]
  • ACL tear and reconstruction [ Time Frame: Year 3-5 ]

Central Contacts and Locations

Central contacts

Xiaojuan Li, PhD

510-685-3495lix6@ccf.org

Jennifer Baldwin

216 390-5833baldwij3@ccf.org

Locations

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Xiaojuan Li, PhD

510-685-3495lix6@ccf.org

More Information

Sponsor

Xiaojuan Li

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Xiaojuan Li on 2026-02-27.