Total-body PET scanning to find disease activity and cardiovascular risk in ANCA-associated vasculitis
PET Assessment of Disease Activity and Cardiovascular Disease Risk in ANCA-associated Vasculitis
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Edinburgh Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Edinburgh) |
| Trial ID | NCT07258524 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Edinburgh
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.