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

This research looks into ANCA-associated vasculitis (AAV), a serious condition where the body's immune system attacks blood vessels, causing inflammation. It can harm different organs and, if untreated, can be life-threatening. Even with treatment, people with AAV have a higher risk of heart disease in the long run. The study uses special full-body PET scans with different tracers to see if they can accurately detect AAV activity and help predict future heart problems. Researchers will compare scan results from AAV patients with a healthy group. The aim is to find better ways to understand and manage AAV, and identify those at risk of heart issues.

At a glance

Status
Recruiting
Sponsor
University of Edinburgh
Enrolment target
120
Start
28 Jan 2026
Estimated completion
01 Jan 2029

What is this study about?

ANCA-associated vasculitis (AAV) is a rare but serious condition. It happens when your body's immune system, which normally fights off infections, mistakenly attacks your small blood vessels. This causes inflammation and damage, which can affect many different organs in your body, such as your kidneys, lungs, and nerves. If left untreated, AAV can be very dangerous, but modern treatments are much better now.

Even with effective treatment, diagnosing AAV can be tricky, and it's hard for doctors to tell how active the disease is at any given time. Current ways to check include blood tests, which aren't always accurate, or biopsies, which involve taking a tissue sample and can be invasive. Also, people with AAV have a higher chance of developing heart and blood vessel problems later in life, like heart attacks or strokes, even when their vasculitis is under control. We need better ways to understand the disease and predict these risks.

This study aims to investigate if a special type of full-body scan, called a PET scan, can help. The researchers will use different dyes with the PET scan to light up areas of inflammation. They hope these scans can accurately show where the AAV is active in the body and also help identify who might be at a greater risk of heart problems down the line. By comparing results from people with AAV and a healthy group, they hope to improve how doctors diagnose, monitor, and treat this condition, ultimately leading to better care for patients.

Key takeaways

  • This study aims to improve AAV diagnosis and monitoring.
  • It uses special full-body PET scans to see disease activity.
  • Researchers also want to predict heart problem risk in AAV patients.
  • It involves AAV patients and a healthy comparison group.
  • Participation includes scans, blood/urine tests, and heart health checks.

Who may be eligible?

To join this study, you need to be at least 18 years old. If you have ANCA-associated vasculitis (AAV), you would need to have an active form of the disease to be considered for the AAV patient group.

There are several reasons why someone might not be able to join. For instance, if you're pregnant or breastfeeding, or if you have severe kidney problems, you wouldn't be able to take part. Also, if you have insulin-dependent diabetes, or if you've had a bad reaction to the types of scanning dyes used in the study, you wouldn't be eligible. Importantly, the first scan for AAV patients needs to happen within three weeks of starting treatment, so if you've been on treatment for longer, you might not qualify.

There's also a group of healthy volunteers without AAV who will take part. These volunteers will be carefully matched to the patients with AAV based on certain characteristics, to ensure fair comparison in the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Do you have active ANCA-associated vasculitis (AAV)? (For AAV group)
  3. Are you NOT pregnant or breastfeeding?
  4. Have you started AAV treatment less than 3 weeks ago? (For AAV group)
  5. Do you NOT have severe kidney problems (eGFR <15)?
  6. Are you NOT on insulin for diabetes?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll have several appointments at the University of Edinburgh BioQuarter.

For everyone, whether you have AAV or are a healthy volunteer, you will have a full-body PET scan. This scan uses small amounts of special dyes (called radiotracers) that help highlight different things in your body. Depending on the group you're in, you might have one, two, or all three types of these dyes. Alongside the scan, you'll also have checks for heart disease risk, which include having your blood pressure measured over 24 hours, checking the stiffness of your arteries, and an eye scan. You will also need to provide blood and urine samples.

If you are a healthy volunteer, your involvement ends after these initial appointments. If you have AAV, you will have these same tests repeated after your condition has settled down and is in remission, which usually happens about 3 to 6 months after starting treatment. The researchers will then compare your scan results and other measurements taken at the beginning and the end.

Potential risks and benefits

Taking part in this study could offer several benefits. You would contribute to a better understanding of ANCA-associated vasculitis and a potential new way to spot heart disease risks, which could help many patients in the future. While the PET scans involve a small amount of radiation, this is kept as low as possible, and generally considered safe. There are also tiny risks associated with providing blood and urine samples, such as minor bruising. You would have the right to withdraw from the study at any time, for any reason, without it affecting your care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University of Edinburgh
    Verified postcode
    Edinburgh, United Kingdom· Recruiting

Common questions

What is ANCA-associated vasculitis (AAV)?

AAV is a condition where your immune system mistakenly attacks your blood vessels, causing inflammation and damage to organs.

What is a PET scan?

A PET scan is a medical imaging test that uses a small amount of a radioactive substance to look for disease in the body.

Why are they studying heart disease risk?

Even with treatment, people with AAV have a higher long-term risk of heart problems like heart attacks and strokes, so researchers want to find ways to detect this early.

Will I have to take any new medicines in this study?

No, this study does not involve new medicines. It focuses on using special scans and other tests to understand your condition.

How long will my involvement in the study last?

If you are a healthy volunteer, your involvement ends after the initial tests. If you have AAV, you will have follow-up tests typically 3-6 months later.

How to find out more

Neeraj Dhaun, MBChB PhD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "PET Assessment of Disease Activity and Cardiovascular Diseas…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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