PET scans to track ANCA-associated vasculitis activity and heart disease risk
Uses PET scans to assess vasculitis activity and heart risk in adults.
Key facts
- Who runs it
- University of Edinburgh
- Where
- Edinburgh, United KingdomSee the site
- Trial code
- Registry title
- PET Assessment of Disease Activity and Cardiovascular Disease Risk in ANCA-associated Vasculitis
- Status
- Recruiting
- People taking part
- 120 people, planned
- Started
- 28 Jan 2026
- Expected to end
- Jan 2029
- Type of study
- Observational, 2 groups
- Record updated
- 12 February 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with active ANCA-associated vasculitis, and also for adults without the disease as a comparison group. Everyone has PET scans and heart and blood vessel checks.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Active ANCA-associated vasculitis (AAV) for the patient group
- Earlier treatment
- The first scan must happen less than 3 weeks after starting treatment
Main reasons for not taking part
- Pregnancy or breastfeeding
- Advanced kidney problems (eGFR <15ml/min/1.73m2)
- Past bad reaction or allergy to the scan tracers
- Insulin-dependent diabetes
- Cannot give informed consent
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 18+ years of age
- Diagnosis of active AAV (AAV group)
Who cannot take part
- Adverse reaction or hypersensitivity to proposed radiotracers
- Insulin-dependent diabetes mellitus
- Advanced renal dysfunction (eGFR <15ml/min/1.73m2)
- Outwith early treatment window (must receive baseline scan <3 weeks from starting treatment)
- Pregnancy or breastfeeding
- Patients without mental capacity or willingness to provide informed consent
Where in United Kingdom
- University of EdinburghEdinburgh, United KingdomContact: Bean Dhaun, MBChB PhDTaking people
About the trial
What the trial wants to find out
Antineutrophil cytoplasm antibody (ANCA)-associated vasculitis (AAV) is a severe autoimmune condition characterised by inflammation of small blood vessels. The condition causes multi-organ dysfunction and, if left untreated, is usually fatal. AAV is difficult to diagnose and the degree of disease activity is challenging to monitor. Current methods of disease activity assessment are either inaccurate (blood tests), invasive (biopsy), or non-specific (imaging). Additionally, though modern treatments are effective, patients with AAV remain at a substantially increased risk of cardiovascular disease (CVD) in the long-term. There is therefore an urgent need for a tool which is able to reliably identify disease, and assess long-term CVD risk.
Read full original descriptionShow less
Total-Body PET imaging with FDG, DOTATATE, and FAPI radiotracers may provide the answer. This study will recruit patients with active AAV, together with a control group of individuals without the disease, to undergo Total-Body FDG, DOTATATE, and FAPI PET scanning and compare the results with established measures of disease activity and CVD risk assessment.
The investigators believe that Total-Body PET scanning will be capable of accurately identifying AAV disease and those at increased CVD risk. This could enhance understanding and improve the management of those with the condition.
This study will recruit a group of patients with AAV and a comparator groups of 'matched' individuals without AAV. Comparisons between groups will allow the investigators to ensure that the changes seen are due to AAV disease. The study will recruit a minimum of 30 and a maximum of 90 participants in the AAV group, and a minimum of 10 and maximum of 30 participants in the matched control group.
AAV subjects and matched control subjects will undergo baseline total-body PET scanning with either one, two or three radiotracers ([18F]-FDG, [68Ga]-DOTATATE, and [68Ga]-FAPI). Alongside this they will receive assessment of cardiovascular disease risk including 24-hour blood pressure measurement, arterial stiffness measurement, and retinal scanning. Participants will also supply a blood and urine sample.
For matched control subjects, their participation will end at this point. Subjects in the AAV group will undergo repeat assessment with total-body PET imaging and cardiovascular disease risk measurement once their condition is in remission (usually after around 3-6 months).
The investigators will compare PET scan results between groups, and with cardiovascular assessments. This will allow determination of whether total-body PET scanning can identify AAV disease activity, and whether it can inform CVD risk.
All research activity will be carried out within the University of Edinburgh BioQuarter, including the Royal infirmary of Edinburgh, the Edinburgh Imaging Facility, and Queen's Medical Research Institute.
The 2 groups in the trial
- ANCA associated vasculitis (AAV) group
All participants will have a diagnosis of ANCA-associated vasculitis (AAV) in accordance with the 2012 Revised International Chapel Hill Consensus Conference Nomenclature of Vasculitides criteria and clinician's assessment. At enrolment, participants in the AAV group will have active disease, as defined by the presence of symptoms and signs attributable to active vasculitis necessitating the commencement or increase in immunosuppressive treatment other than glucocorticoids. In order to return for the follow-up visit, participants will be in clinical remission. Remission will be defined as Birmingham Vasculitis Activity Score (BVAS) = 0 for at least two months whilst taking prednisolone at a daily of dose ≤7.5mg in conjunction with the treating clinician's assessment of clinically silent disease.
- Matched control group
All participants will be matched with the AAV group based on age, gender, ethnicity, and cardiovascular disease risk factors including impaired kidney function. They will have no additional health problems and be taking no additional medications (other than those relevant to cardiovascular disease risk) that may interfere with PET imaging.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- PET Assessment of Disease Activity and Cardiovascular Disease Risk in ANCA-associated Vasculitis
- Plain-language title
- PET scans to track ANCA-associated vasculitis activity and heart disease riskGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 12 February 2026