Clinical trial Recruiting at 1 site Observational Ages 18 and up

Total-body PET scanning to find disease activity and cardiovascular risk in ANCA-associated vasculitis

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

Run by University of Edinburgh · NCT07258524 · Data updated 2026-11-12

We will test whether whole-body PET scans with FDG, DOTATATE, and FAPI can detect active inflammation and identify people with active ANCA-associated vasculitis who are at higher long-term cardiovascular risk.

More ANCA Associated Vasculitis (AAV) trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment120 (estimated)
SponsorUniversity of Edinburgh
Academic / other
Drugs / interventionsradiation
Locations1 site (Edinburgh)
StatusRecruiting
StartedJanuary 28, 2026
Main results expectedJanuary 2029
Study endsJanuary 2029
Registry record updatedFebruary 12, 2026
Trial IDNCT07258524 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (18+) with active ANCA-associated vasculitis who can attend the University of Edinburgh for total-body PET scanning within three weeks of starting treatment and who meet safety criteria (not pregnant/breastfeeding, eGFR ≥15 ml/min/1.73 m2, not insulin-dependent diabetic, no tracer hypersensitivity) are ideal candidates.

Probably not a fit

People with inactive or well-controlled disease, those who cannot undergo PET scanning (for example due to pregnancy, advanced renal failure, insulin-dependent diabetes, or tracer allergy), or those who cannot be scanned within the early treatment window are unlikely to benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational project will recruit adults with active ANCA-associated vasculitis and a control group without the disease to undergo total-body PET imaging using FDG, DOTATATE, and FAPI tracers. Baseline scans are planned early in therapy (within three weeks of starting treatment) and imaging findings will be compared with clinical data, blood tests, and standard imaging to characterise disease activity. The study will also examine whether PET-derived measures of inflammation associate with markers of long-term cardiovascular risk. People who are pregnant, breastfeeding, have very low kidney function, insulin-dependent diabetes, or known hypersensitivity to the tracers are excluded.

Why it matters

Potential benefit: If successful, this approach could offer a noninvasive way to detect smouldering vascular inflammation and better identify patients at increased long-term cardiovascular risk so care can be more precisely targeted.

How similar studies have gone: FDG PET has shown promise in other vasculitis types, but using total-body FDG alongside DOTATATE and FAPI in ANCA-associated vasculitis is relatively novel and not yet established.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • University of Edinburgh
    Edinburgh, United Kingdom
    Recruiting

Study contacts

  • Principal investigator: Neeraj Dhaun, MBChB PhD — University of Edinburgh
  • Study coordinator: Neeraj Dhaun, MBChB PhD
  • Email: bean.dhaun@ed.ac.uk
  • Phone: 01312426777

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.