Knee Osteoarthritis Clinical Trial
— GENU-PERFOfficial title:
Evaluation of the Diagnostic Value of a Biomarker of Non-surgical Knee Osteoarthritis: Subchondral Bone Perfusion (GENU-PERF)
NCT number | NCT04324554 |
Other study ID # | RC-P0081 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 31, 2021 |
Est. completion date | September 2024 |
Osteoarthritis is a very common pathology, especially in an aging population, and a source of disability. Based on standard radiography, the diagnosis is performed late based on the loss of the cartilage thickness. In this context, prosthetic replacement of the joint is a frequent outcome. New diagnostic biomarkers and herapeutic targets are therefore logically research priorities identified by the European League Against Rheumatisms, osteoarthritis ad hoc committee. The inflammation related to the development of this pathology is mainly studied at the cellular level and essentially in animals. Since inflammatory and vascular phenomena are closely intertwined, medical imaging of the subchondral bone vascularization appears interesting. The dynamic contrast-enhanced T1 Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) technique allows the identification of changes in the osteoarthritic subchondral bone vascularization. In osteoarthritic animals, these changes could be identified before the cartilaginous lesions became visible, and could be correlated with the severity of osteoarthritis. This study would be the first to correlate subchondral bone perfusion measurements (performed with the DCE sequence) of early cartilaginous lesions of the knee, identified by non-invasive MRI (T2 mapping) in humans. This examination will be performed on a 3 Tesla MRI. If a correlation is demonstrated in the early stages of osteoarthritis in both humans and animals, then infusion of subchondral bone could become a biomarker of osteoarthritis, and serve as a follow-up evaluation of future treatments.
Status | Recruiting |
Enrollment | 130 |
Est. completion date | September 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 59 Years |
Eligibility | Inclusion Criteria: - Patients = 18 years old and < 60 years old - Asymptomatic at the patella-femoral joint - Coming to perform a medical imaging examination for another indication, in the medical imaging department of the GHICL - Patient being informed and given free, informed and written consent to participate - Affiliated to the social security Exclusion Criteria: - Medical history of traumatic ligamentous, meniscal or cartilaginous lesion - Medical history of knee surgery - Contraindications to MRI (pacemaker, ferromagnetic vascular clip, infusion pump, neurostimulator, cochlear implant, suspicion of metallic foreign body, claustrophobia, ...) - MRI with gadoteric acid injection in the 7 days preceding the MRI of the knee - Hypersensitivity to gadoteric acid, meglumine or any drug containing gadolinium, or any other contrast medium - Medical history of severe allergy, uncontrolled asthma, treatment with beta-blocker - Renal insufficiency: glomerular filtration less than 30 mL/min - Pregnant or nursing woman - Patient under tutorship or curatorship |
Country | Name | City | State |
---|---|---|---|
France | Lille Catholic Hospitals | Lomme | Nord |
Lead Sponsor | Collaborator |
---|---|
Lille Catholic University |
France,
Conaghan PG, Kloppenburg M, Schett G, Bijlsma JW; EULAR osteoarthritis ad hoc committee. Osteoarthritis research priorities: a report from a EULAR ad hoc expert committee. Ann Rheum Dis. 2014 Aug;73(8):1442-5. doi: 10.1136/annrheumdis-2013-204660. Epub 2014 Mar 13. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlation between T2 cartilage value and endothelial transfer constant (Ktrans) | T2 (transverse relaxation time) mapping can evaluate the status of the cartilage matrix and identify biochemical changes. T2 is the time constant which determines the rate at which excited protons reach equilibrium or go out of phase with each other. It is a measure of the time taken for spinning protons to lose phase coherence among the nuclei spinning perpendicular to the main field. Ktrans is a constant representing the volume transfer between blood plasma and extravascular extracellular space. its units are given in values of (1/time) |
Thirty minutes after MRI | |
Primary | Correlation between T2 cartilage value and reflux rate (Kep) | The infusion pharmacokinetics parameters are as follows: Ktrans, Kep Kep represents the time constant for gadolinium reflux from the extravascular extracellular space back into the vascular system |
Thirty minutes after MRI | |
Primary | Correlation between T2 cartilage value and initial slope of the kinetic curve | The infusion non-pharmacokinetics parameters are as follows: - initial slope, time at peak, area under the curve |
Thirty minutes after MRI | |
Primary | Correlation between T2 cartilage value and area under the kinetic curve | The infusion non-pharmacokinetics parameters are as follows: - initial slope, time at peak, area under the curve |
Thirty minutes after MRI | |
Primary | Correlation between T2 cartilage value and time at peak | The infusion non-pharmacokinetics parameters are as follows: - initial slope, time at peak, area under the curve |
Thirty minutes after MRI |
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