Rheumatoid ArthritisNCT02361385
PBR28 PET and Inflammatory Arthritis
An observational study of Rheumatoid Arthritis and Psoriatic Arthritis, run by University of Oxford at 2 sites in United Kingdom.
Trial summary
The importance of the detection of early inflammatory arthritis is recognised as being essential to the prevention of permanent joint damage. Furthermore, drug development in inflammatory arthritis is in increasing need of imaging that is able to sensitively and accurately detect and quantify inflammation in a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Psoriatic Arthritis
- What is being tested?
- this is not an interventional study
- How many people
- 22 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Mar 2015to Jul 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with known rheumatoid arthritis or psoriatic arthritis, with at least one swollen joint, with evidence of joint inflammation in the feet and/or ankles (on clinical examination and/or ultrasound)
Who may be able to join
- Patients with known rheumatoid arthritis or psoriatic arthritis, with at least one swollen joint, with evidence of joint inflammation in the feet and/or ankles (on clinical examination and/or ultrasound)
Who cannot join
- pregnant and breastfeeding patients those with metalwork in feet/ankles patients unable to lie on their back Patient has been identified as a low affinity [11C]PBR28 binder according to peripheral blood genotyping assay The patient has any significant co-morbidity precluding participation as judged by the study doctor
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Imanova Centre for Imaging Sciences
London, Greater London, W12 0NN
Nuffield Orthopaedic Centre
Oxford, Oxfordshire, OX3 7LD
About this study
Official title: Pilot Study to Evaluate the Feasibility of [11C]PBR28 PET-CT to Image Inflammation in the Joints of Arthritis Patients
The importance of the detection of early inflammatory arthritis is recognised as being essential to the prevention of permanent joint damage. Furthermore, drug development in inflammatory arthritis is in increasing need of imaging that is able to sensitively and accurately detect and quantify inflammation in a reproducible and objective manner. There is an increasing body of evidence to support the role of PET-CT for these indications. The PET tracer 11CPBR28 is specific to the translocator protein (TSPO) highly expressed on activated macrophages. In this proof of principle study, the investigators aim to ascertain whether or not the PET tracer 11CPBR28 is taken up in inflamed joints. The investigators also aim to explore the significance of TSPO to inflammatory arthritis, through blood and joint lining samples.
Read the detailed description
The investigators aim to recruit a minimum of 12 patients with known, active rheumatoid or psoriatic arthritis in the feet and ankles. Patients will first undergo a screening genotyping test; low affinity binders for PBR28 PET will be excluded from this pilot study. Those patients meeting inclusion criteria, will then undergo a PET-CT localised to feet and ankles that have been identified to be clinically inflamed (on examination and ultrasound at the screening visit). After PET-CT, patients will undergo synovial biopsy of one joint imaged. After 6 patients have undergone PET-CT, an interim analysis will be undertaken, to optimise PET scan duration and to alter the group of joints being imaged with CT.
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis
- Being tested
- this is not an interventional study
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
this is not an interventional studyOther
this is not an interventional study; this is a pilot feasibility study to see whether or not 11CPR28 will be taken up in joints of those known to have active arthritis clinically
| Study group | Role | What they receive |
|---|---|---|
| this is a pilot study | All patients will undergo PET-CT with PBR28, with the CT being localised to one group of joints only Receives: Other: this is not an interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
standardised uptake values (SUV)
Evidence of uptake of 11CPBR28 in the inflamed feet and/or ankle joints of patients with known rheumatoid or psoriatic arthritis as exhibited by SUV (standard uptake values) on the PET-CT images.
Measured: maximum duration of scan is 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Imanova Centre for Imaging Sciences
- Responsible party
- Sponsor
- Investigators
- Peter Taylor, MA,BChB,FRCP, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361385
- Sponsor's protocol ID
- 11132
- Status last verified
- May 2018
- First submitted
- 6 Feb 2015
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Feasibility of [11C]PBR28 PET-CT to Image Inflammation in the Joints of Arthritis Patients
- ClinicalTrials.gov ID
- NCT02361385
- Acronym / sponsor ID
- 11132
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Imanova Centre for Imaging Sciences
- Study start
- Mar 2015 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 11 Feb 2015 (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 importance of the detection of early inflammatory arthritis is recognised as being essential to the prevention of permanent joint damage. Furthermore, drug development in inflammatory arthritis is in increasing need of imaging that is able to sensitively and accurately detect and quantify inflammation in a reproducible and objective manner. There is an increasing body of evidence to support the role of PET-CT for these indications. The PET tracer 11CPBR28 is specific to the translocator protein (TSPO) highly expressed on activated macrophages. In this proof of principle study, the investigators aim to ascertain whether or not the PET tracer 11CPBR28 is taken up in inflamed joints. The investigators also aim to explore the significance of TSPO to inflammatory arthritis, through blood and joint lining samples.
Detailed description
The investigators aim to recruit a minimum of 12 patients with known, active rheumatoid or psoriatic arthritis in the feet and ankles. Patients will first undergo a screening genotyping test; low affinity binders for PBR28 PET will be excluded from this pilot study. Those patients meeting inclusion criteria, will then undergo a PET-CT localised to feet and ankles that have been identified to be clinically inflamed (on examination and ultrasound at the screening visit). After PET-CT, patients will undergo synovial biopsy of one joint imaged. After 6 patients have undergone PET-CT, an interim analysis will be undertaken, to optimise PET scan duration and to alter the group of joints being imaged with CT.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| this is a pilot study | – | Other: this is not an interventional studyAll patients will undergo PET-CT with PBR28, with the CT being localised to one group of joints only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with known rheumatoid arthritis or psoriatic arthritis, with at least one swollen joint, with evidence of joint inflammation in the feet and/or ankles (on clinical examination and/or ultrasound)
Key inclusion criteria (1 listed)
- Patients with known rheumatoid arthritis or psoriatic arthritis, with at least one swollen joint, with evidence of joint inflammation in the feet and/or ankles (on clinical examination and/or ultrasound)
Key exclusion criteria (1 listed)
- pregnant and breastfeeding patients those with metalwork in feet/ankles patients unable to lie on their back Patient has been identified as a low affinity [11C]PBR28 binder according to peripheral blood genotyping assay The patient has any significant co-morbidity precluding participation as judged by the study doctor
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 |
|---|---|---|
| this is not an interventional studythis is not an interventional study; this is a pilot feasibility study to see whether or not 11CPR28 will be taken up in joints of those known to have active arthritis clinically | Other | this is a pilot study |
Primary outcome
standardised uptake values (SUV)
Time frame: maximum duration of scan is 90 minutes
Evidence of uptake of 11CPBR28 in the inflamed feet and/or ankle joints of patients with known rheumatoid or psoriatic arthritis as exhibited by SUV (standard uptake values) on the PET-CT images.
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 12 Oct 2018.
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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.
Peter Taylor, MA,BChB,FRCP principal investigator
University of Oxford
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Psoriatic Arthritis, run by University of Oxford at 2 sites 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 1 inclusion and 1 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 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
standardised uptake values (SUV) (time frame: maximum duration of scan is 90 minutes). 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 12 Oct 2018.