NCT07258524 PET Assessment of Disease Activity and Cardiovascular Disease Risk in ANCA-associated Vasculitis
| NCT ID | NCT07258524 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Edinburgh |
| Condition | ANCA Associated Vasculitis (AAV) |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-01-28 |
| Primary Completion | 2029-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2026-01-28 with a primary completion date of 2029-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. 18+ years of age 2. Diagnosis of active AAV (AAV group) Exclusion Criteria: 1. Outwith early treatment window (must receive baseline scan \<3 weeks from starting treatment) 2. Pregnancy or breastfeeding 3. Advanced renal dysfunction (eGFR \<15ml/min/1.73m2) 4. Adverse reaction or hypersensitivity to proposed radiotracers 5. Insulin-dependent diabetes mellitus 6. Patients without mental capacity or willingness to provide informed consent
Contact & Investigator
Neeraj Dhaun, MBChB PhD
PRINCIPAL INVESTIGATOR
University of Edinburgh
Frequently Asked Questions
Who can join the NCT07258524 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying ANCA Associated Vasculitis (AAV). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07258524 currently recruiting?
Yes, NCT07258524 is actively recruiting participants. Contact the research team at bean.dhaun@ed.ac.uk for enrollment information.
Where is the NCT07258524 trial being conducted?
This trial is being conducted at Edinburgh, United Kingdom.
Who is sponsoring the NCT07258524 clinical trial?
NCT07258524 is sponsored by University of Edinburgh. The principal investigator is Neeraj Dhaun, MBChB PhD at University of Edinburgh. The trial plans to enroll 120 participants.