NCT02350426

A Study to Assess Inflammation in Rheumatoid Arthritis Using Molecular Imaging Techniques

Terminated Phase 1 Last updated 4 December 2017

What this trial tests

Phase 1 trial testing Gadobutrol in Arthritis, Rheumatoid in 10 participants. Terminated before completion.

Timeline

12 August 2015

Primary endpoint
26 October 2016

26 October 2016

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	10
Start date	12 August 2015
Primary completion	26 October 2016
Estimated completion	26 October 2016
Sites	2 locations across United Kingdom

Drugs / interventions tested

• Gadobutrol (GADOBUTROL) — full drug profile →
• 18F-FDG — full drug profile →
• 18F-GE-180

Conditions studied

• Arthritis, Rheumatoid — all drugs for Arthritis, Rheumatoid →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 30 to 85, any sex, with Arthritis, Rheumatoid. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an adaptive Positron Emission Tomography/ Computed Tomography (PET/CT) and Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) open-label study design for the investigation of inflammation in adult rheumatoid arthritis (RA) patients, not involving therapeutic intervention. Each study participant will undergo two half body PET/CT scans from the pelvis to the bottom of the feet (including hands and wrists) with an additional bed position centred on the shoulders. One scan will be conducted with 18F-FDG and the other with 18F-GE-180. The first PET/CT scan (PET1) will be performed 4 weeks (28 +/- 2 days) after the first screening visit, whereas the second PET/CT scan (PET2) will be carried out within 2 weeks (7 +/- 7 days) after PET1. The order of PET/CT scans for each subject will be based on a computer generated randomisation schedule after the screening visit. A sub-group of study participants will be invited to undergo an additional dynamic 18F-GE-180 PET scan of a selected joint (knee or wrist) prior to their 18F-GE-180 PET/CT half body scan. The primary objective of the study is to quantify inflammation in joints of RA patients by determining 18F-FDG and 18F-GE-180 uptake using PET, and DCE-MRI parameters.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Quantifying disease activity in rheumatoid arthritis with the TSPO PET ligand ¹⁸F-GE-180 and comparison with ¹⁸F-FDG and DCE-MRI.
   de Groot M, Patel N, Manavaki R, Janiczek RL, et al · · 2019 · cited 12× · PMID 31858293 · DOI 10.1186/s13550-019-0576-8