Multi-Vendor Multi-Site Novel Accelerated MRI Relaxometry

Recruiting now

Conditions studied: Bone Diseases, Infectious, Musculoskeletal Diseases, Joint Diseases, Osteoarthritis, ACL Tear, Cartilage Degeneration

In brief

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 facts

Study ID

NCT04536103

Run by

Xiaojuan Li

People needed

88

Starts

2022-04-01

Expected to finish

2026-12-28

Last updated by the study team

2026-02-27

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

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.
• History of osteoarthritis and inflammatory arthritis
• Previous injury and/or surgery on either knee

Where it is running

• Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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