Multi-Vendor Multi-Site Novel Accelerated MRI Relaxometry

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
View:

⁃ 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

Locations
United States
Ohio
Cleveland Clinic Foundation
RECRUITING
Cleveland
Contact Information
Primary
Xiaojuan Li, PhD
lix6@ccf.org
510-685-3495
Backup
Jennifer Baldwin
baldwij3@ccf.org
216 390-5833
Time Frame
Start Date: 2022-04-01
Estimated Completion Date: 2026-12-28
Participants
Target number of participants: 88
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Xiaojuan Li

This content was sourced from clinicaltrials.gov