NCT04536103 Multi-Vendor Multi-Site Novel Accelerated MRI Relaxometry
| NCT ID | NCT04536103 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xiaojuan Li |
| Condition | Bone Diseases, Infectious |
| Study Type | OBSERVATIONAL |
| Enrollment | 88 participants |
| Start Date | 2022-04-01 |
| Primary Completion | 2026-02-24 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 88 participants in total. It began in 2022-04-01 with a primary completion date of 2026-02-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Xiaojuan Li
PRINCIPAL INVESTIGATOR
Director, Program for Advanced Musculoskeletal Imaging
Frequently Asked Questions
Who can join the NCT04536103 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Bone Diseases, Infectious. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04536103 currently recruiting?
Yes, NCT04536103 is actively recruiting participants. Contact the research team at lix6@ccf.org for enrollment information.
Where is the NCT04536103 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT04536103 clinical trial?
NCT04536103 is sponsored by Xiaojuan Li. The principal investigator is Xiaojuan Li at Director, Program for Advanced Musculoskeletal Imaging. The trial plans to enroll 88 participants.