Knee OsteoarthritisGENU-PERFNCT04324554
Diagnostic Value of a Biomarker of Non-surgical Knee Osteoarthritis
An observational study of Knee Osteoarthritis, run by Lille Catholic University at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- MRI of the right knee
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 31 Aug 2021to Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Asymptomatic persons coming to perform a medical imaging examination for another indication, in the medical imaging department of the GHICL.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Renal insufficiency: glomerular filtration less than 30 mL/min
- Pregnant or nursing woman
- Patient under tutorship or curatorship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Lille Catholic Hospitals
Lomme, Nord, 59462
Amélie Lansiaux, Md, PhD, 03 20 22 52 69 ext. +33, lansiaux.amelie@ghicl.net
Anne-Sophie Blain, CRA, 03 20 22 57 32 ext. +33, blain.anne-sophie@ghicl.net
About this study
Official title: Evaluation of the Diagnostic Value of a Biomarker of Non-surgical Knee Osteoarthritis: Subchondral Bone Perfusion (GENU-PERF)
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.
Read more
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.
Read the detailed description
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 because it is based on the loss of cartilage thickness. In this context, prosthetic replacement of the joint is a frequent outcome. New diagnostic biomarkers and new therapeutic targets are therefore logically research priorities identified up today by the European League Against Rheumatisms, osteoarthritis ad hoc committee .
The strictly mechanical nature of osteoarthritis is currently being questioned. Indeed, the primitive role of inflammation in the development of this pathology is more and more discussed. This inflammation is today 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.
In humans, a preliminary investigator study has recently shown that these changes correlate with the importance of osteoarthritic lesions in patients with advanced osteoarthritis. Up to date, no clinical study has so far been initiated to evaluate the diagnostic value of vascularization markers of subchondral bone in early knee osteoarthritis.
In this context, this prospective monocentric study aims to define the role of DCE medical imaging in the diagnosis of early (non-surgical) patella-femoral osteoarthritis.
This study would be the first to correlate subchondral bone perfusion measurements (performed with the DCE sequence) with early cartilaginous lesions, 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
- Being tested
- MRI of the right knee
- Keywords
- Knee Osteoarthritis, Subchondral bone, DCE-MRI
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI of the right kneeDiagnostic test
An MRI of the right knee will be done to define the role of imaging in the diagnosis of early femoro-patellar osteoarthritis.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: MRI of the right knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Thirty minutes after MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start31 Aug 2021
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-François BUDZIK, Pr, Principal investigator, Lille Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04324554
- Sponsor's protocol ID
- RC-P0081
- Acronym
- GENU-PERF
- Status last verified
- Nov 2022
- First submitted
- 24 Mar 2020
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24625626
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Diagnostic Value of a Biomarker of Non-surgical Knee Osteoarthritis: Subchondral Bone Perfusion (GENU-PERF)
- ClinicalTrials.gov ID
- NCT04324554
- Acronym / sponsor ID
- GENU-PERF / RC-P0081
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, Subchondral bone, DCE-MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 27 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 because it is based on the loss of cartilage thickness. In this context, prosthetic replacement of the joint is a frequent outcome. New diagnostic biomarkers and new therapeutic targets are therefore logically research priorities identified up today by the European League Against Rheumatisms, osteoarthritis ad hoc committee .
The strictly mechanical nature of osteoarthritis is currently being questioned. Indeed, the primitive role of inflammation in the development of this pathology is more and more discussed. This inflammation is today 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.
In humans, a preliminary investigator study has recently shown that these changes correlate with the importance of osteoarthritic lesions in patients with advanced osteoarthritis. Up to date, no clinical study has so far been initiated to evaluate the diagnostic value of vascularization markers of subchondral bone in early knee osteoarthritis.
In this context, this prospective monocentric study aims to define the role of DCE medical imaging in the diagnosis of early (non-surgical) patella-femoral osteoarthritis.
This study would be the first to correlate subchondral bone perfusion measurements (performed with the DCE sequence) with early cartilaginous lesions, 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI of the right knee | – | Diagnostic Test: MRI of the right kneeAn MRI of the right knee will be done to define the role of imaging in the diagnosis of early femoro-patellar osteoarthritis. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Asymptomatic persons coming to perform a medical imaging examination for another indication, in the medical imaging department of the GHICL.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI of the right kneeAn 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 |
Primary outcome
Correlation between T2 cartilage value and endothelial transfer constant (Ktrans)
Time frame: Thirty minutes after MRI
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)
Correlation between T2 cartilage value and reflux rate (Kep)
Time frame: Thirty minutes after MRI
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
Correlation between T2 cartilage value and initial slope of the kinetic curve
Time frame: Thirty minutes after MRI
The infusion non-pharmacokinetics parameters are as follows: - initial slope, time at peak, area under the curve
Correlation between T2 cartilage value and area under the kinetic curve
Time frame: Thirty minutes after MRI
The infusion non-pharmacokinetics parameters are as follows: - initial slope, time at peak, area under the curve
Correlation between T2 cartilage value and time at peak
Time frame: Thirty minutes after MRI
The infusion non-pharmacokinetics parameters are as follows: - initial slope, time at peak, area under the curve
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Background: PubMed 24625626Conaghan 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.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-François BUDZIK, Pr principal investigator
Lille Catholic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Lille Catholic University at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amélie Lansiaux, Md, PhD (03 20 22 52 69 ext. +33, lansiaux.amelie@ghicl.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between T2 cartilage value and endothelial transfer constant (Ktrans) (time frame: Thirty minutes after MRI). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04324554, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022.