OsteoarthritisAMROANCT02883907
Advanced MR Imaging of Osteoarthritis
An observational study of Osteoarthritis, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The utility of conventional imaging in the development of new treatments for osteoarthritis (OA) is hindered by: 1. Difficulty in non-invasively evaluating the initial response to potential new treatment options. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Apr 2017to 1 Nov 2018
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Group 1 will consist of 10 patients aged 40-60 who have presented to the Orthopaedic clinic with a painful knee, and have mild/moderate OA on plain radiographs (Kellgren-Lawrence grade 2-3). Group 2 will consist of 5 healthy volunteer controls, matched (1:2 ratio) to cases for age, sex and body mass index who do not have knee pain.
Who may be able to join
None listed.
Who cannot join
- History of ipsilateral lower limb fracture
- History of ipsilateral lower limb surgery (including arthroscopy)
- Metabolic bone disease
- Inflammatory arthritis
- Haematological malignancy
- Paget's disease
Show all 10Show fewer
- Bone metastases
- Contraindication to MR imaging (e.g. pacemaker, severe claustrophobia)
- Contraindication to intravenous gadolinium based contrast medium administration (see 'Ethical Considerations' section)
- Unable to consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB2 0QQ
About this study
The utility of conventional imaging in the development of new treatments for osteoarthritis (OA) is hindered by:
- Difficulty in non-invasively evaluating the initial response to potential new treatment options. OA typically develops over a long time period, so evaluating the efficacy of new treatment options over a timeframe relevant to experimental medicine studies is difficult.
- Inadequate methods of disease quantification and stratification. OA is a heterogeneous condition and identifying which subgroups of patients are most likely to benefit from new treatments is crucial.
Read more
Novel magnetic resonance (MR) imaging acquisition and analysis techniques have the potential to solve these problems. However, their reliability needs to be fully established and knowledge of likely effect sizes is required to inform sample size considerations for further longitudinal/interventional studies.
This study aims to help address these issues by:
- Calculating effect sizes for MR measurements to inform sample size calculations for future studies.
- Assessing the reliability of a multiparametric MR protocol for assessment of the knee joint.
The investigators will examine a single knee of an initial 15 participants with MR. Participants will be drawn from two groups: (1) 10 participants aged 40-60 years old with clinical and x-ray features of OA and (2) 5 control subjects (matched to cases for age, sex and body mass index in a 1:2 ratio) who do not have clinical features of OA.
Participants will undergo an initial (baseline) MR examination, followed by repeat MR examinations at approximately 1 month and 1 year following the baseline examination.
This will allow us to assess both the reliability of our MR measurements and the expected progression in our MR measurements in OA subjects in the absence of any disease-modifying intervention.
- Conditions
- Osteoarthritis
- Medical subject headings
- Osteoarthritis
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 | Not described | |
| Osteoarthritis patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean cartilage T1rho relaxation time (milliseconds)
Measured: 1 year
Mean cartilage T2 relaxation time (milliseconds)
Measured: 1 year
Mean cartilage T1 relaxation time post gadolinium (milliseconds)
Derived from delayed gadolinium enhanced MR of cartilage (dGEMRIC)
Measured: 1 year
Secondary outcomes (6)
Modified Osteoarthritis Knee Score (MOAKS) (arbitrary units)
Semiquantitative scoring system
Measured: 1 year
Cartilage thickness values (millimeters)
Surface-based comparison using statistical parametric mapping
Measured: 1 year
Subchondral bone area (millimeters squared)
Measured: 1 year
Dynamic contrast enhanced (DCE) quantitation of parameters
Multiple DCE parameters calculated allowing description of enhancement rate and pattern of synovium
Measured: 1 year
Subchondral bone texture index (arbitrary units)
Measured: 1 year
Osteochondral junction integrity (semiquantitative grading, arbitrary units)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study start27 Apr 2017
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamie MacKay, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883907
- Sponsor's protocol ID
- 609/M/C/1670
- Acronym
- AMROA
- Status last verified
- Jan 2019
- First submitted
- 22 Aug 2016
- Last updated
- 15 Jan 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced MR Imaging of Osteoarthritis
- ClinicalTrials.gov ID
- NCT02883907
- Acronym / sponsor ID
- AMROA / 609/M/C/1670
- Conditions
- Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 27 Apr 2017 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 30 Aug 2016 (estimated)
- 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 utility of conventional imaging in the development of new treatments for osteoarthritis (OA) is hindered by:
- Difficulty in non-invasively evaluating the initial response to potential new treatment options. OA typically develops over a long time period, so evaluating the efficacy of new treatment options over a timeframe relevant to experimental medicine studies is difficult.
- Inadequate methods of disease quantification and stratification. OA is a heterogeneous condition and identifying which subgroups of patients are most likely to benefit from new treatments is crucial.
Novel magnetic resonance (MR) imaging acquisition and analysis techniques have the potential to solve these problems. However, their reliability needs to be fully established and knowledge of likely effect sizes is required to inform sample size considerations for further longitudinal/interventional studies.
This study aims to help address these issues by:
- Calculating effect sizes for MR measurements to inform sample size calculations for future studies.
- Assessing the reliability of a multiparametric MR protocol for assessment of the knee joint.
The investigators will examine a single knee of an initial 15 participants with MR. Participants will be drawn from two groups: (1) 10 participants aged 40-60 years old with clinical and x-ray features of OA and (2) 5 control subjects (matched to cases for age, sex and body mass index in a 1:2 ratio) who do not have clinical features of OA.
Participants will undergo an initial (baseline) MR examination, followed by repeat MR examinations at approximately 1 month and 1 year following the baseline examination.
This will allow us to assess both the reliability of our MR measurements and the expected progression in our MR measurements in OA subjects in the absence of any disease-modifying intervention.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | – |
| Osteoarthritis patients | – | – |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Group 1 will consist of 10 patients aged 40-60 who have presented to the Orthopaedic clinic with a painful knee, and have mild/moderate OA on plain radiographs (Kellgren-Lawrence grade 2-3). Group 2 will consist of 5 healthy volunteer controls, matched (1:2 ratio) to cases for age, sex and body mass index who do not have knee pain.
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- History of ipsilateral lower limb fracture
- History of ipsilateral lower limb surgery (including arthroscopy)
- Metabolic bone disease
- Inflammatory arthritis
- Haematological malignancy
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
Mean cartilage T1rho relaxation time (milliseconds)
Time frame: 1 year
Mean cartilage T2 relaxation time (milliseconds)
Time frame: 1 year
Mean cartilage T1 relaxation time post gadolinium (milliseconds)
Time frame: 1 year
Derived from delayed gadolinium enhanced MR of cartilage (dGEMRIC)
6 secondary outcomes
Modified Osteoarthritis Knee Score (MOAKS) (arbitrary units)
Time frame: 1 year
Cartilage thickness values (millimeters)
Time frame: 1 year
Subchondral bone area (millimeters squared)
Time frame: 1 year
Dynamic contrast enhanced (DCE) quantitation of parameters
Time frame: 1 year
Subchondral bone texture index (arbitrary units)
Time frame: 1 year
Osteochondral junction integrity (semiquantitative grading, arbitrary units)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Osteoarthritis, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 0 inclusion and 10 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: finished, as of the sponsor's last update on 15 Jan 2019. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean cartilage T1rho relaxation time (milliseconds) (time frame: 1 year). The study lists 3 primary outcomes in all. 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 15 Jan 2019.