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Hybrid Florbetaben PET/MRI for Imaging of Cardiac Amyloidosis

This research is looking into a new way of scanning the heart using something called 'hybrid Florbetaben PET/MRI'. This special scan combines two types of imaging to get a very detailed picture of the heart in people who have a condition called cardiac amyloidosis. We want to see if the information from these scans can help doctors predict future heart problems, like needing to go to the hospital for heart failure or other serious heart events. By comparing the results from these new scans with other tests like MRI and echocardiograms, we hope to find better ways to understand and monitor heart amyloidosis. Ultimately, this could help doctors provide more personalised and effective care.

At a glance

Status
Recruiting
Sponsor
University Hospital, Essen
Enrolment target
25
Start
09 Dec 2019
Estimated completion
01 Dec 2025

What is this study about?

This study is about understanding how a condition called cardiac amyloidosis affects the heart. Cardiac amyloidosis happens when abnormal proteins, called amyloid, build up in the heart muscle, making it stiff and difficult for it to pump blood properly. This can lead to serious heart problems.

Researchers are using a special type of scan called a 'hybrid Florbetaben PET/MRI' scan. This combines two powerful imaging techniques: PET (Positron Emission Tomography) and MRI (Magnetic Resonance Imaging). By doing this, they can get very detailed pictures of the heart and look for specific signs of amyloid build-up. The main goal is to find out if the information gathered from these scans can help predict which patients are more likely to experience major heart-related events in the future, such as hospital stays due to heart failure or other serious complications.

They will compare the results from these advanced scans with other standard heart tests, including regular MRI scans and echocardiograms (ultrasound scans of the heart). By doing this, they hope to identify the most useful ways to monitor cardiac amyloidosis and ultimately help doctors manage the condition better, potentially leading to earlier intervention and improved care for patients.

Key takeaways

  • Study uses special PET/MRI scans to look at heart amyloidosis.
  • Aims to predict future heart problems in patients.
  • Compares new scans to standard tests like MRI and echocardiograms.
  • No new medication or treatment involved, it's an observational study.
  • Could help improve how doctors monitor and manage cardiac amyloidosis.
  • Participation involves a scan and follow-up of your health.

Who may be eligible?

To join this study, you need to be at least 40 years old and have a confirmed diagnosis of amyloidosis (either ATTR or AL type). If you are a woman, you'll need to have a negative pregnancy test shortly before the scans are done.

However, there are reasons why you might not be able to take part. You can't join if you are already receiving specific treatment for your amyloidosis, or if you are currently involved in another clinical study looking at amyloidosis treatments. Pregnancy is also a reason not to join.

Also, if you have certain health conditions or medical devices that make having an MRI scan unsafe (like certain metallic implants, severe kidney problems, or an allergy to the dye used in MRI scans), you won't be able to participate. Finally, you must be able and willing to understand and agree to take part 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 40 years old or older?
  2. Have you been diagnosed with ATTR or AL amyloidosis?
  3. Are you currently pregnant, or could you be pregnant?
  4. Are you receiving specific treatment for your amyloidosis right now?
  5. Do you have any medical conditions or implants that prevent you from having an MRI scan?
Answer every question to see your result.

What does participation involve?

This study involves undergoing a special 'hybrid Florbetaben PET/MRI' scan. This means you will have both a PET scan and an MRI scan of your heart, likely at the same appointment. You will also have other standard checks, like an echocardiogram (an ultrasound scan of your heart). The researchers will then follow your health over time to see if there are any major heart-related events. This helps them understand whether the information from the scans can predict your future health. They will collect information from your medical records regarding any heart events that occur.

Potential risks and benefits

Participating in this study might help researchers learn more about cardiac amyloidosis, potentially leading to better care for patients in the future. There are no direct personal health benefits in terms of treatment, as this study is observational (meaning it only involves scans and follow-up, not new medication). Potential risks relate mainly to the scans themselves, such as exposure to a small amount of radiation from the PET scan, and the usual risks associated with MRI scans like feeling confined or potential reactions to the contrast dye. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

  • Department of Nuclear medicine, University Hospital Essen
    Verified postcode
    Essen, Germany· Recruiting

Common questions

What is cardiac amyloidosis?

It's a condition where abnormal proteins called amyloid build up in your heart, making it stiff and harder for it to pump blood properly.

What is a 'hybrid PET/MRI' scan?

It's a special type of scan that combines two powerful imaging methods, PET and MRI, to get very detailed pictures of your heart.

Will I receive new treatment in this study?

No, this study is about using scans to understand your condition better, not about testing new treatments. You will continue to receive your usual medical care.

How long will I be involved in the study?

You will have a scan and other tests, and then the researchers will follow your health over time to see how the amyloidosis progresses. The exact follow-up duration is not specified but involves tracking heart-related events.

What are 'major adverse cardiac events (MACE)'?

These are serious heart-related problems researchers will track, like needing to be hospitalised for heart failure or other significant heart issues.

How to find out more

David Kersting, MD, 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 "Hybrid Florbetaben PET/MRI for Imaging of Cardiac Amyloidosi…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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