Clinical Trials Directory

Trials / Completed

CompletedNCT03914248

Monitoring Large Vessel Vasculitis With PET/MR Imaging

Monitoring Large Vessel Vasculitis With PET/MR Imaging: an Exploratory Study

Status
Completed
Phase
Study type
Observational
Enrollment
27 (actual)
Sponsor
University of Edinburgh · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Large vessel vasculitis (LVV) causes blood vessel inflammation leading to pain, fatigue and complications such as aneurysm formation and stroke. Treatments used can have significant side-effects. Doctors find it difficult to determine when to start and stop treatment, often leading to over- or under-treatment. A new test is required to determine disease activity that will guide treatment more accurately. This study will recruit participants with active LVV from throughout Scotland in order to assess the ability of two new types of scan - positron emission tomography with magnetic resonance imaging (PET/MR) and retinal optical coherence tomography (OCT) - to determine disease activity. In addition, I will investigate the link between LVV and heart disease.

Detailed description

Large vessel vasculitis (LVV) is a multi-system, autoimmune disease characterised by non-specific symptoms, pain and high glucocorticoid requirements. The lack of a robust biomarker that tracks disease activity makes disease monitoring difficult. This leads to both disease over-treatment, resulting in adverse effects of glucocorticoids, and under-treatment, with the potential for significant vascular complications. Additionally, the link between LVV and cardiovascular disease (CVD), which is the main cause of death in these patients, remains poorly characterised. An imaging tool which is capable of accurately monitoring disease activity over time is urgently required. Positron emission tomography with magnetic resonance imaging (PET/MR) and retinal optical coherence tomography (OCT) have the potential to meet this need. PET/MR is uniquely useful for imaging CVD and utilises \~50% of the radiation dose of PET with computerised tomography. OCT is a novel potential biomarker of microvascular dysfunction, systemic inflammation and CVD risk in small vessel vasculitis. Participants with a new diagnosis or recent flare of LVV will undergo serial PET/MR and OCT scanning alongside established measures of CVD risk. Results will be compared with current clinical measures of disease activity and with banked control data.

Conditions

Timeline

Start date
2019-07-01
Primary completion
2022-01-26
Completion
2022-01-26
First posted
2019-04-16
Last updated
2022-05-24

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT03914248. Inclusion in this directory is not an endorsement.