AuthorisedPhase I and Phase II (Integrated)- First administration to humansInterventional

POSITRON EMISSION TOMOGRAPHY/COMPUTED TOMOGRAPHY STUDY FOR SAFETY, TOLERABILITY, BIODISTRIBUTION AND PERFORMANCE OF [68Ga]Ga-DOTA-SIGLEC-9 FOLLOWING A SINGLE INTRAVENOUS ADMINISTRATION IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS, VASCULITIS OR PULMONARY SARCOIDOSIS AS WELL AS RADIATION DOSIMETRY, PLASMA PHARMACOKINETICS, BIODISTRIBUTION OF THE TRACER IN HEALTHY VOLUNTEERS

This research study is investigating a new imaging scan called a PET/CT scan. It uses a very small amount of a special substance called a 'tracer' which contains a tiny bit of radioactivity. The main goals are to check if this tracer is safe, how well the body tolerates it, and how it spreads throughout the body in people with active rheumatoid arthritis, vasculitis, or pulmonary sarcoidosis. These are conditions where the body's immune system attacks its own tissues. Researchers also want to see how well this new scan can detect areas of inflammation that are linked to these conditions. The study is also looking at how the tracer works in healthy volunteers. This is an early stage study (Phase I and II), meaning it's one of the first times this tracer is being given to people.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Turku University Hospital

Enrolment target

Start

29 Jan 2025

active arthritis vasculitis pulmonary sarcoidosis

What is this study about?

This study is looking at a new way to get a clear picture of what's going on inside the body, especially in people with certain conditions where the body's immune system is overactive. These conditions include active rheumatoid arthritis (which causes painful, swollen joints), vasculitis (where blood vessels become inflamed), and pulmonary sarcoidosis (which can cause small lumps or growths in the lungs and other organs).

The new method uses a special scan called a PET/CT scan, along with a small amount of a substance called a 'tracer'. This tracer is designed to go to specific places in the body where there's inflammation. By using the scan, doctors hope to see these inflamed areas more clearly. This could help them understand these conditions better and potentially find new ways to monitor them in the future.

This is an early-stage study, which means it’s one of the first times this particular tracer is being tested in people. The main aims are to check if it's safe and well-tolerated, how the body handles it, and how well it helps to 'light up' areas of inflammation on the scan. The study is being carried out in people with these conditions, as well as in healthy volunteers, to get a full picture of how the tracer behaves.

Key takeaways

This study uses a new PET/CT scan with a special 'tracer' to look at inflammation.
It's for people with active rheumatoid arthritis, vasculitis, or pulmonary sarcoidosis, and healthy volunteers.
The main goals are to check the tracer's safety, how the body handles it, and how well it shows inflammation.
It's an early-stage study, one of the first times this tracer is being used in people.
Participation involves receiving the tracer, having scans, and blood tests.

Who may be eligible?

To be considered for this study, you need to be an adult, 18 years old or older. Both men and women can take part.

If you have active rheumatoid arthritis, vasculitis, or pulmonary sarcoidosis, and these conditions are currently causing you symptoms or problems, you might be eligible. The study is specifically looking for people whose conditions are 'active'.

If you are a healthy volunteer, meaning you don't have these conditions and are generally well, you might also be able to take part. This helps the researchers compare how the tracer works in people who are unwell versus those who are healthy.

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.

Are you 18 years old or older?
Do you have active rheumatoid arthritis, vasculitis, or pulmonary sarcoidosis?
Or are you a healthy adult volunteer?
Are you able to attend study visits and scans?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you'll receive a single administration of the special tracer, which will be given into your vein. Before and after this, you'll have several tests, including the special PET/CT scans, blood tests to see how the tracer moves through your body, and possibly other check-ups to make sure you're well. The specific number of visits and the total length of your participation will be explained in detail by the study team. They will also tell you if there are any specific things you need to do or avoid, like certain medications, during the study period. You will have regular appointments for assessments and follow-up.

Potential risks and benefits

Participating in research always carries potential benefits and risks. A potential benefit could be helping doctors learn more about these inflammatory conditions, which might lead to better ways to diagnose or treat them in the future. You might also receive extra monitoring related to your condition during the study. Potential risks include side effects from the tracer, exposure to a small amount of radiation from the scans, and discomfort from injections or blood samples. It’s important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Finland

Common questions

What is a PET/CT scan?

It's a special type of scan that combines two different imaging techniques to give doctors detailed pictures of what's happening inside your body, including how your organs and tissues are working.

What is a 'tracer'?

It's a very small amount of a substance that contains a tiny bit of radioactivity, which helps it show up on the PET scan. It's designed to go to specific parts of your body, allowing doctors to see things they wouldn't normally.

What does 'active' rheumatoid arthritis, vasculitis, or sarcoidosis mean?

It means your condition is currently causing symptoms or showing signs of inflammation and disease activity, rather than being in a quiet or stable phase.

Will I be given medication as part of this study?

This study is focused on the tracer and scans. You will receive a single dose of the tracer, but it's not a treatment or medication for your condition. Any existing treatments you are on will be discussed with the study team.

What is a 'Phase I and II' study?

These are early phases of clinical trials. Phase I mainly checks safety and how the tracer acts in the body, while Phase II starts to look at how well it works and continues to monitor safety, often in a slightly larger group of people.