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Multi-Vendor Multi-Site Novel Accelerated MRI Relaxometry (MVMS_MRI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04536103
Recruitment Status : Recruiting
First Posted : September 2, 2020
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

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.

Condition or disease Intervention/treatment
Bone Diseases, Infectious Musculoskeletal Diseases Joint Diseases Osteoarthritis ACL Tear Cartilage Degeneration Diagnostic Test: MRI

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Study Type : Observational
Estimated Enrollment : 88 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Multi-Vendor Multi-Site Novel Accelerated MRI Relaxometry
Estimated Study Start Date : October 1, 2021
Estimated Primary Completion Date : February 10, 2026
Estimated Study Completion Date : December 28, 2026

Group/Cohort Intervention/treatment
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.
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.
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
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Subjects between the ages of 18-50 years old. And subjects who sustain an acute full ACL tear in one knee with the contralateral knee uninjured.
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

Information from the National Library of Medicine

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


Contacts
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Contact: Xiaojuan Li, PhD 510-685-3495 lix6@ccf.org
Contact: Jennifer Turczyk 216 390-5833 turczyj@ccf.org

Locations
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United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Xiaojuan Li, PhD    510-685-3495    lix6@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Xiaojuan Li Director, Program for Advanced Musculoskeletal Imaging
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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT04536103    
Other Study ID Numbers: 20-599
First Posted: September 2, 2020    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021

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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
Additional relevant MeSH terms:
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Communicable Diseases
Infections
Bone Diseases, Infectious
Joint Diseases
Bone Diseases
Musculoskeletal Diseases
Disease Attributes
Pathologic Processes