PBR28 PET and Inflammatory Arthritis

NCT02361385 | Completed DMC

• 1 other identifier: 11132
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 2

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.

Conditions

Rheumatoid Arthritis; Psoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

this is not an interventional study OTHER

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

this is a pilot study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead
• Imanova Centre for Imaging Sciences: collaborator

Study Sites (2)

Imanova Centre for Imaging Sciences

London, Greater London, W12 0NN, United Kingdom

Location

Nuffield Orthopaedic Centre

Oxford, Oxfordshire, OX3 7LD, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

A single blood sample will be taken for a genotyping test, to ascertain whether or not individuals are suitable to undergo PET-CT with the PBR28 PET tracer. Further, blood samples will be taken for serum and RNA, and synovial biopsy will be done.

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases

Study Officials

• Peter Taylor, MA,BChB,FRCP

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2015
• First Posted: February 11, 2015
• Study Start: March 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 12, 2018

Record last verified: 2018-05

Locations

GB (2)