Knee OsteoarthritisNCT06063304
Quantitative MRI For Detection and Tracking of Knee Osteoarthritis
An observational study of Knee Osteoarthritis, run by Imperial College London.
Trial summary
The goal of this observational study is to develop whole-joint quantitative MRI techniques that aid in the detection and tracking of osteoarthritis disease progression at 3T and 7T MRI scanners. The research objectives are: 1. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Sep 2026
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The research team will be recruiting both healthy volunteers and early knee osteoarthritis patients using the inclusion and exclusion criteria detailed above.
Who may be able to join
- All people between 40 to 70 years of age
- All people with no history of knee injury, surgery, or knee pain
- All patients with primary osteoarthritis (grade 2-3 per Kellgren-Lawrence Scale)
- Patients who have had radiographs taken as part of their routine clinical care agreed with their orthopaedic surgeon, Mr Gareth Jones. Note that their radiographs must have been acquired a maximum of three weeks from the first, baseline scanning session. This radiograph will be used to check if patients have primary osteoarthritis.
- All patients between 40 to 70 years of age
Who cannot join
- Patients with body mass index of more than 35, or body geometry that prevents scanning due to MRI scanner bore width or knee coil diameter
- Patients with varus or valgus malalignment
- Patients with contraindications to MRI
- Patients lacking capacity to consent
- Patients who are pregnant or breast-feeding
- Patients who are participating in a clinical trial(s) for new drugs and/or therapies
Show all 13Show fewer
- Patients with body mass index of more than 35, or body geometry that prevents scanning due to MRI scanner bore width or knee coil diameter
- Patients with varus or valgus malalignment of more than 5°
- Patients with radiographic osteoarthritis (grade ≥4 per Kellgren-Lawrence Scale, obtained from radiographs)
- Patients with contraindications to MRI
- Patients lacking capacity to consent
- Patients who are pregnant or breast-feeding
- Patients who are participating in a clinical trial(s) for new drugs and/or therapies
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Quantitative MRI For Detection And Tracking of Disease Progression Over 2 Years In Early Knee Osteoarthritis Patients & Healthy Volunteers
The goal of this observational study is to develop whole-joint quantitative MRI techniques that aid in the detection and tracking of osteoarthritis disease progression at 3T and 7T MRI scanners. The research objectives are:
- Compare the relative accuracies of 7T and 3T MRI in detecting clinical osteoarthritis progression.
- Compare the quantitative MRI measures developed with the results acquired from the following two questionnaires: Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Visual Analogue Score (VAS).
- Measure the repeatability of 7T and 3T quantitative MRI methods developed in whole-joint knee imaging
- Optimize the quality and efficiency of 7T and 3T whole-joint knee MRI
Read more
Participants will be scanned at the 3T scanner at the Clinical Imaging Facility at Hammersmith Hospital and/or the 7T scanner at the LOCUS Center at St Thomas' Hospital. Knee osteoarthritis volunteers will be asked to fill out two questionnaires and will be scanned 4 times over a 2 year period (at enrolment, after 6 months, after 12 months and after 24 months) while healthy volunteers will be scanned once at enrolment. Both healthy volunteers and knee osteoarthritis patients will be asked to fill out MRI safety forms before entering the scanner room, and both groups will be scanned up to 90 minutes during each session.
Researchers will compare knee osteoarthritis patients with healthy volunteers to see how their knee anatomy and tissue properties differ.
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, Healthy Volunteer, 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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | This group consists of healthy volunteers with no history of knee joint pain (refer to inclusion/exclusion criteria for more details). They will be scanned once and their scans will be used as the baseline to compare the early knee osteoarthritis patient data with. 10 healthy volunteers will be recruited. | |
| Knee Osteoarthritis Patients | This group consists of early knee osteoarthritis patients (refer to inclusion/exclusion criteria for more details). They will be scanned 4 times over a period of 2 years (at enrolment, 6 months, 12 months and 24 months after enrolment) to see how the disease progresses. Their scans will be compared with the baseline healthy volunteer scans to check for any differences in anatomy and tissue properties. 60 knee osteoarthritis patients will be recruited. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproducibility of cartilage thickness values at 3T and 7T as a measure of knee osteoarthritis at enrolment, after 6 months, after 12 months and after 24 months
The cartilage thickness values will be calculated from the MRI scans that will be acquired.
Measured: at enrolment, after 6 months, after 12 months and after 24 months
Secondary outcomes (6)
Reproducibility of microstructure maps at 3T and 7T as a measure of knee osteoarthritis at enrolment, after 6 months, after 12 months and after 24 months
The microstructure maps will be calculated from the MRI scans that will be acquired.
Measured: at enrolment, after 6 months, after 12 months and after 24 months
Reproducibility of MOAKS analysis at 3T and 7T as a measure of knee osteoarthritis at enrolment, after 6 months, after 12 months and after 24 months
MRI Osteoarthritis Knee Score (MOAKS) values will be calculated from the MRI scans that will be acquired. MOAKS is a semi-quantitative scoring tool that scores sub-regions of articular cartilage and bone marrow lesions. Different grades are used to score each sub-region. For cartilage sub-region loss, grade 0 indicates no loss and grade 3 indicates over 75% loss.
Measured: at enrolment, after 6 months, after 12 months and after 24 months
Calculate and compare the longitudinal changes in cartilage thickness at 3T and 7T over the 2 year period
Cartilage thickness will be calculated for scans acquired at the various time points on the 3T and 7T scanners and compared with each other to investigate the change in thickness over the specified time frame.
Measured: at enrolment, after 6 months, after 12 months and after 24 months
Calculate and compare the longitudinal changes in microstructure maps at 3T and 7T over the 2 year period
Microstructure maps will be calculated for scans acquired at the various time points on the 3T and 7T scanners and compared with each other to investigate the change in thickness over the specified time frame.
Measured: at enrolment, after 6 months, after 12 months and after 24 months
Calculate minimum detectable effect size for osteoarthritis progression at 3T and 7T with cartilage thickness
Measured: at enrolment, after 6 months, after 12 months and after 24 months
Calculate minimum detectable effect size for osteoarthritis progression at 3T and 7T with microstructure maps
Measured: at enrolment, after 6 months, after 12 months and after 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study startOct 2023 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust
- Responsible party
- Sponsor
- Investigators
- Neal K Bangerter, PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06063304
- Sponsor's protocol ID
- 22IC8098
- Status last verified
- Sep 2023
- First submitted
- 8 Sep 2023
- Last updated
- 2 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not be sharing IPD with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative MRI For Detection And Tracking of Disease Progression Over 2 Years In Early Knee Osteoarthritis Patients & Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06063304
- Acronym / sponsor ID
- 22IC8098
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, Healthy Volunteer, MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust
- Study start
- Oct 2023 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 2 Oct 2023 (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.
The goal of this observational study is to develop whole-joint quantitative MRI techniques that aid in the detection and tracking of osteoarthritis disease progression at 3T and 7T MRI scanners. The research objectives are:
- Compare the relative accuracies of 7T and 3T MRI in detecting clinical osteoarthritis progression.
- Compare the quantitative MRI measures developed with the results acquired from the following two questionnaires: Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Visual Analogue Score (VAS).
- Measure the repeatability of 7T and 3T quantitative MRI methods developed in whole-joint knee imaging
- Optimize the quality and efficiency of 7T and 3T whole-joint knee MRI
Participants will be scanned at the 3T scanner at the Clinical Imaging Facility at Hammersmith Hospital and/or the 7T scanner at the LOCUS Center at St Thomas' Hospital. Knee osteoarthritis volunteers will be asked to fill out two questionnaires and will be scanned 4 times over a 2 year period (at enrolment, after 6 months, after 12 months and after 24 months) while healthy volunteers will be scanned once at enrolment. Both healthy volunteers and knee osteoarthritis patients will be asked to fill out MRI safety forms before entering the scanner room, and both groups will be scanned up to 90 minutes during each session.
Researchers will compare knee osteoarthritis patients with healthy volunteers to see how their knee anatomy and tissue properties differ.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –This group consists of healthy volunteers with no history of knee joint pain (refer to inclusion/exclusion criteria for more details). They will be scanned once and their scans will be used as the baseline to compare the early knee osteoarthritis patient data with. 10 healthy volunteers will be recruited. |
| Knee Osteoarthritis Patients | – | –This group consists of early knee osteoarthritis patients (refer to inclusion/exclusion criteria for more details). They will be scanned 4 times over a period of 2 years (at enrolment, 6 months, 12 months and 24 months after enrolment) to see how the disease progresses. Their scans will be compared with the baseline healthy volunteer scans to check for any differences in anatomy and tissue properties. 60 knee osteoarthritis patients will be recruited. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The research team will be recruiting both healthy volunteers and early knee osteoarthritis patients using the inclusion and exclusion criteria detailed above.
Key inclusion criteria (5 listed)
- All people between 40 to 70 years of age
- All people with no history of knee injury, surgery, or knee pain
- All patients with primary osteoarthritis (grade 2-3 per Kellgren-Lawrence Scale)
- Patients who have had radiographs taken as part of their routine clinical care agreed with their orthopaedic surgeon, Mr Gareth Jones. Note that their radiographs must have been acquired a maximum of three weeks from the first, baseline scanning session. This radiograph will be used to check if patients have primary osteoarthritis.
- All patients between 40 to 70 years of age
Key exclusion criteria (13 listed)
- Patients with body mass index of more than 35, or body geometry that prevents scanning due to MRI scanner bore width or knee coil diameter
- Patients with varus or valgus malalignment
- Patients with contraindications to MRI
- Patients lacking capacity to consent
- Patients who are pregnant or breast-feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reproducibility of cartilage thickness values at 3T and 7T as a measure of knee osteoarthritis at enrolment, after 6 months, after 12 months and after 24 months
Time frame: at enrolment, after 6 months, after 12 months and after 24 months
The cartilage thickness values will be calculated from the MRI scans that will be acquired.
6 secondary outcomes
Reproducibility of microstructure maps at 3T and 7T as a measure of knee osteoarthritis at enrolment, after 6 months, after 12 months and after 24 months
Time frame: at enrolment, after 6 months, after 12 months and after 24 months
Reproducibility of MOAKS analysis at 3T and 7T as a measure of knee osteoarthritis at enrolment, after 6 months, after 12 months and after 24 months
Time frame: at enrolment, after 6 months, after 12 months and after 24 months
Calculate and compare the longitudinal changes in cartilage thickness at 3T and 7T over the 2 year period
Time frame: at enrolment, after 6 months, after 12 months and after 24 months
Calculate and compare the longitudinal changes in microstructure maps at 3T and 7T over the 2 year period
Time frame: at enrolment, after 6 months, after 12 months and after 24 months
Calculate minimum detectable effect size for osteoarthritis progression at 3T and 7T with cartilage thickness
Time frame: at enrolment, after 6 months, after 12 months and after 24 months
Calculate minimum detectable effect size for osteoarthritis progression at 3T and 7T with microstructure maps
Time frame: at enrolment, after 6 months, after 12 months and after 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Individual participant dataSharing planned: No. We will not be sharing IPD with other researchers.
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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.
Neal K Bangerter, PhD principal investigator
Imperial College London
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Imperial College London.
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 13 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 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Neal K Bangerter, PhD (7534066791 ext. +44, n.bangerter@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reproducibility of cartilage thickness values at 3T and 7T as a measure of knee osteoarthritis at enrolment, after 6 months, after 12 months and after 24 months (time frame: at enrolment, after 6 months, after 12 months and after 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2023.