PET Assessment of Disease Activity and Cardiovascular Disease Risk in ANCA-associated Vasculitis

NCT07258524 | Recruiting

• 1 other identifier: AC25078
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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.

Conditions

ANCA Associated Vasculitis (AAV)

Keywords

ANCA; Vasculitis; PET scanning

Outcome Measures

Primary Outcomes (1)

• Change in tracer ([18F]-FDG, [68Ga]-DOTATATE, and [68Ga]-FAPI) uptake (calculated using maximum standardised uptake values (SUVmax)) within regions of interest between baseline and remission)

  The change in PET radiotracer uptake within regions of interest between patients with active AAV (e.g. at baseline) and patients in remission (e.g. at follow-up)

  3-12 months

Secondary Outcomes (2)

• Correlation between tracer uptake (SUVmax and SUVmean) and established measures of disease activity including: o CRP o ANCA titre o Patient reported disease activity o Physician estimated disease activity

  3-12 months

• Correlation between tracer uptake (SUVmax and SUVmean) and established surrogate measures of CVD risk including: o Arterial stiffness o 24-hour ambulatory blood pressure o Retinal OCT imaging metrics

  3-12 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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. 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.

You may qualify if:

• + years of age
• Diagnosis of active AAV (AAV group)

You may not qualify if:

• Outwith early treatment window (must receive baseline scan \<3 weeks from starting treatment)
• Pregnancy or breastfeeding
• Advanced renal dysfunction (eGFR \<15ml/min/1.73m2)
• Adverse reaction or hypersensitivity to proposed radiotracers
• Insulin-dependent diabetes mellitus
• Patients without mental capacity or willingness to provide informed consent

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

University of Edinburgh

Edinburgh, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine

MeSH Terms

Conditions

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Vasculitis

Condition Hierarchy (Ancestors)

Systemic Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Neeraj Dhaun, MBChB PhD

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neeraj Dhaun, MBChB PhD

CONTACT

01312426777; bean.dhaun@ed.ac.uk

Dan Pugh, MBChB PhD

CONTACT

01312426777; dpugh2@ed.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 2, 2025
• Study Start: January 28, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)