Monitoring Large Vessel Vasculitis With PET/MR Imaging

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

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.

Study Overview

• Status: Completed
• Conditions: Large Vessel Vasculitis

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.

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• United Kingdom
  • Edinburgh, United Kingdom, EH164TJ
    • University of Edinburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from outpatient clinics throughout Scotland

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Active large vessel vasculitis; PET/MR scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum standardised uptake values (SUVmax)	Maximum standardised uptake values (SUVmax) will be assessed using PETMR. This information will be used to quantify disease activity and atheroma at pre-specified vascular segments.	0 and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Choroidal thickness in microns	Assessment of choroidal thickness as measured using optical coherence tomography will be made at baseline and 6 months	0 and 6 months
Choroidal volume in mm3	Assessment of choroidal volume using optical coherence tomography will be made at baseline and 6 months	0 and 6 months
Retinal vasculature morphology	Visual assessment of arteriolar thickness, branching coefficient and branching angle, fractal dimension, and venular tortuosity will be made using OPTOS imaging at baseline and 6 months	0 and 6 months
24-hour ambulatory blood pressure in mmHg	Assessment of 24-hour ambulatory systolic and diastolic blood pressure will be made at baseline and 6 months	0 and 6 months
Pulse wave velocity	Assessment of arterial stiffness will be made using pulse wave velocity as measured using SphygmoCor technology. Percentage change in pulse wave velocity will be compared between baseline and 6 months	0 and 6 months

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Investigators: Principal Investigator: Neeraj Dhaun, MBChB PhD, University of Edinburgh

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2019
• Primary Completion (ACTUAL): January 26, 2022
• Study Completion (ACTUAL): January 26, 2022

Study Registration Dates

• First Submitted: April 2, 2019
• First Submitted That Met QC Criteria: April 10, 2019
• First Posted (ACTUAL): April 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 23, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Vasculitis
• Other Study ID Numbers: E182026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No