Diagnostic Value of a Biomarker of Non-surgical Knee Osteoarthritis

NCT04324554 | Unknown

• 1 other identifier: RC-P0081
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis; Subchondral bone; DCE-MRI

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

MRI of the right knee

An MRI of the right knee will be done to define the role of imaging in the diagnosis of early femoro-patellar osteoarthritis.

Diagnostic Test: MRI of the right knee

Interventions

MRI of the right knee DIAGNOSTIC_TEST

An MRI of the right knee will be done to define the role of imaging in the diagnosis of early femoro-patellar osteoarthritis.

MRI of the right knee

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Asymptomatic persons coming to perform a medical imaging examination for another indication, in the medical imaging department of the GHICL.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lille Catholic University: lead

Study Sites (1)

Lille Catholic Hospitals

Lomme, Nord, 59462, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 24625626 BACKGROUND

Related Links

• Osteoarthritis (OA) currently affects over 40 million Europeans, with its associated personal suffering and significant economic burden for health systems set to dramatically escalate in a rapidly ageing Europe.

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Jean-François BUDZIK, Pr

  Lille Catholic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amélie Lansiaux, Md, PhD

CONTACT

03 20 22 52 69; lansiaux.amelie@ghicl.net

Anne-Sophie Blain, CRA

CONTACT

03 20 22 57 32; blain.anne-sophie@ghicl.net

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: March 27, 2020
• Study Start: August 31, 2021
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: December 1, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)