Monitoring Large Vessel Vasculitis With PET/MR Imaging

NCT ID: NCT03914248

Last Updated: 2022-05-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 27 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2022-01-26

Brief 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

Large Vessel Vasculitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Active large vessel vasculitis

PET/MR scan

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• A new diagnosis of LVV or a known diagnosis of LVV presenting with disease relapse

Exclusion Criteria

• Predominantly cranial symptoms
• LVV secondary to other conditions
• Treatment with high dose glucocorticoids for >2 weeks at time of recruitment
• Contraindication to MR or PET
• Unable to travel to Edinburgh
• Estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m2
• Unable to provide informed consent
• Pregnant or breastfeeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Edinburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neeraj Dhaun, MBChB PhD

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Locations

University of Edinburgh

Edinburgh, , United Kingdom

Countries

United Kingdom

Other Identifiers

E182026

Identifier Type: -

Identifier Source: org_study_id