Prospective, monocentric, exploratory phase II study for the evaluation of the diagnostic use of the tracer PET (18F) -Flutemetamol (Vizamyl®) in patients with cardiac amyloidosis
This research study is about a type of heart disease called cardiac amyloidosis. We are using a special imaging technique called a PET scan with a substance called Vizamyl. Vizamyl is given as an injection and helps highlight certain things in the body so we can see them on the scan. We want to see how much of this tracer is taken up by the heart in people who have different kinds of cardiac amyloidosis. We'll also compare this uptake in various types of amyloidosis and look for any other areas in the body where the tracer might be picked up, which could show us where amyloid deposits are located. The aim is to understand if this scan can help doctors diagnose and monitor these conditions better.
At a glance
What is this study about?
This study is looking at a serious heart condition called cardiac amyloidosis. In this condition, abnormal protein clumps, called amyloid, build up in the heart muscle, making it stiff and difficult for it to pump blood properly. There are different types of cardiac amyloidosis, and diagnosing them accurately can be challenging. This study focuses on using a special imaging test called a PET scan.
During the PET scan, a small amount of a substance called Vizamyl, which is slightly radioactive, will be injected into your body. This substance is designed to attach to the amyloid deposits. The PET scanner then detects the radiation from Vizamyl, allowing doctors to see where these deposits are in the heart. The main goal of this study is to measure exactly how much Vizamyl is taken up by the heart in people with different types of cardiac amyloidosis. We'll be looking at people with ATTRwt, ATTRv, and AL types of cardiac amyloidosis.
By carefully measuring how much Vizamyl the heart takes up, the researchers hope to learn if this PET scan can help differentiate between the different types of cardiac amyloidosis. They will also look to see if the scan can find amyloid in other parts of the body. Ultimately, the aim is to see if this new way of scanning could become a better tool for doctors to diagnose and manage people with cardiac amyloidosis.
Key takeaways
- This study uses a PET scan with a substance called Vizamyl to look at heart conditions.
- It aims to measure how Vizamyl is taken up by the heart in people with cardiac amyloidosis.
- Researchers hope to better understand and distinguish between different types of cardiac amyloidosis.
- This is an early-stage study, exploring a new diagnostic tool for heart disease.
- Participants will receive an injection and undergo a PET scan.
Who may be eligible?
To join this study, people generally need to be at least 18 years old. Both men and women can take part. There isn't an upper age limit mentioned, meaning older adults may also be able to participate. The study is specifically looking for people who have been diagnosed with certain types of cardiac amyloidosis.
Specifically, they are interested in individuals with ATTRwt, ATTRv, or AL types of cardiac amyloidosis. They also want to include people who might have ATTR amyloidosis but whose previous scans (called scintigraphy) showed unclear or negative results. This helps them understand if the new Vizamyl PET scan can be more useful in these tricky cases. If you have been diagnosed with any of these conditions, you might be a good fit for this 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.
- Are you 18 years old or older?
- Do you have a diagnosis of cardiac amyloidosis (ATTRwt, ATTRv, or AL type)?
- Are you interested in participating in a study involving an injection and a PET scan?
- Are you able to travel to the study location if required?
What does participation involve?
If you decide to take part in this study, you will receive an injection of Vizamyl, a liquid containing a very small amount of a radioactive substance. This will be followed by a PET scan, which is a type of imaging test. The main purpose of this scan is to measure how much of the Vizamyl is taken up by your heart. You may also undergo other standard medical assessments during your participation. The study is an 'exploratory' phase, meaning it's an early stage of testing this new approach. The total duration of your participation would likely involve one or a few visits for the scan and any related tests.
Potential risks and benefits
Locations (1)
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Common questions
What is cardiac amyloidosis?
It's a heart condition where abnormal protein builds up in the heart muscle, making it stiff and harder for it to pump blood.
What is Vizamyl?
Vizamyl is a special substance given as an injection that helps doctors see amyloid deposits in the heart during a PET scan.
What is a PET scan?
A PET scan is a type of imaging test that uses a small amount of a radioactive substance to create detailed pictures inside your body, helping doctors see how organs are working.
Will I get radiation from the scan?
Yes, but it's a very small, controlled amount, similar to what you might get from other common medical scans.
Who can join this study?
Anyone aged 18 or over with a diagnosis of certain types of cardiac amyloidosis (ATTRwt, ATTRv, or AL) may be eligible.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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