A research study involving imaging patients with rheumatoid arhtritis
Research type
Research Study
Full title
An Adaptive Design, Open Label Pilot Study in Rheumatoid Arthritis Patients to Assess Inflammation Using Molecular Imaging Techniques.
IRAS ID
159537
Contact name
Deepak Jadon
Contact email
Sponsor organisation
GlaxoSmithKline Research and Development
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Two medical imaging techniques are used in patients with rheumatoid arthritis (RA patients) to image the joints, which are DCE-MRI (Dynamic contrast-enhanced Magnetic Resonance Imaging) and PET-CT (Positron Emission Tomography and Computerised Tomography). In DCE-MRI, a contrast agent that highlights water in the blood (known as gadolinium) is injected. Commonly in PET-CT a sugar (glucose) is chemically modified with a low level of radioactivity. It is called a tracer, known as 18F-FDG. It is injected and taken up by inflamed joints, which will show on the PET-CT. However 18F-FDG is also taken up by other tissues of the body besides inflamed RA joints. A tracer that would only be taken up by macrophages, a cell type in the blood contributing much of the inflammation in RA, may allow improved imaging of joints in RA patients. Another tracer, called 18F-GE-180, is taken up by macrophages. Imaging of RA joints with DCE-MRI or PET-CT with 18F-FDG or 18F-GE-180 will be compared at the end of the study.
Up to 20 RA patients will take part in the study. During the first study visit, the patients will be injected with either 18F-FDG or 18F-GE-180 and undergo a PET-CT scan.
During the second study visit (a maximum of 2 weeks after the first study visit), patients will be injected with 18F-FDG or 18F-GE-180, depending on which they received during the first visit, and undergo a second PET-CT scan. Up to Twelve patients will have additional PET scans of single joints when they are injected with 18F-GE-180. All patients will have DCE-MRI on single joints during the study visit at which they receive 18F-FDG.
The study is sponsored by GSK, a pharmaceutical company, and conducted in collaboration between the GSK Clinical Unit in Cambridge, The University of Cambridge and Cambridge University Hospitals NHS Foundation Trust.REC name
South Central - Oxford A Research Ethics Committee
REC reference
14/SC/1405
Date of REC Opinion
18 Dec 2014
REC opinion
Further Information Favourable Opinion