Clinical trial NCT02361385: PBR28 PET and Inflammatory Arthritis
Official title: Pilot Study to Evaluate the Feasibility of [11C]PBR28 PET-CT to Image Inflammation in the Joints of Arthritis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Psoriatic Arthritis
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Imanova Centre for Imaging Sciences
First posted: 2015-02-11
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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)

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: standardised uptake values (SUV)
timeFrame: maximum duration of scan is 90 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imanova Centre for Imaging Sciences
state: Greater London
city: Oxford
country: United Kingdom
facility: Nuffield Orthopaedic Centre
state: Oxfordshire
Study officials:
affiliation: University of Oxford
name: Peter Taylor, MA,BChB,FRCP
role: PRINCIPAL_INVESTIGATOR
References: