PBR28 PET and Inflammatory Arthritis

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis; Psoriatic Arthritis
• Intervention / Treatment: Other: this is not an interventional study

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 Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• United Kingdom
  • Greater London
    • London, Greater London, United Kingdom, W12 0NN
      • Imanova Centre for Imaging Sciences
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 7LD
      • Nuffield Orthopaedic Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
this is a pilot study; All patients will undergo PET-CT with PBR28, with the CT being localised to one group of joints only	Other: this is not an interventional study; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	maximum duration of scan is 90 minutes

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: Imanova Centre for Imaging Sciences
• Investigators: Principal Investigator: Peter Taylor, MA,BChB,FRCP, University of Oxford

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2015
• Primary Completion (ACTUAL): July 1, 2017
• Study Completion (ACTUAL): July 1, 2017

Study Registration Dates

• First Submitted: February 6, 2015
• First Submitted That Met QC Criteria: February 6, 2015
• First Posted (ESTIMATE): February 11, 2015

Study Record Updates

• Last Update Posted (ACTUAL): October 12, 2018
• Last Update Submitted That Met QC Criteria: October 11, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Psoriatic
• Other Study ID Numbers: 11132