Test-retest Study With [18F]FBB in Cardiac Amyloidosis
This study aims to understand how accurately and consistently a special type of scan, called a PET scan, can detect and measure amyloid protein deposits in the heart. These deposits are linked to a condition called cardiac amyloidosis. We'll use a substance called Florbetaben F18, which helps these deposits show up on the scan. We’ll be performing the scan twice on participants to see if the results are consistent. We're comparing people with different types of cardiac amyloidosis to healthy volunteers. This research will help doctors understand if this scan is a dependable tool for monitoring the condition and how treatments might be working in the future.
At a glance
What is this study about?
This study is investigating a heart condition called cardiac amyloidosis. In this condition, abnormal protein deposits, called amyloid, build up in the heart, making it harder for the heart to pump blood effectively. This can lead to serious health problems. The study focuses on a special imaging technique called a PET scan, which uses a small amount of a safe, traceable substance called Florbetaben F18. This substance helps the amyloid deposits in the heart light up on the scan, making them visible to doctors.
The main goal of this research is to see how accurate and consistent this PET scan is at finding and measuring these amyloid deposits. To do this, participants will have the PET scan done more than once. By comparing the results from these repeated scans, researchers can determine how reliable the scan is – meaning, if it gives similar results each time it's performed on the same person.
Understanding the reliability of this scanning method is very important. If the scan is shown to be consistent, it could become a valuable tool for doctors to diagnose cardiac amyloidosis, track the progression of the disease, and assess how well treatments are working. This study aims to provide clearer information that could ultimately improve care for people living with this condition.
Key takeaways
- This study evaluates a special heart scan using Florbetaben F18.
- It aims to check how reliably the scan detects amyloid deposits in the heart.
- Participants will have the PET scan twice to compare results.
- Results could help doctors better diagnose and monitor cardiac amyloidosis.
- You must be at least 40 years old to participate.
- Contraception rules apply for both men and women due to the scan substance.
Who may be eligible?
To join this study, you need to be at least 40 years old. Both men and women can take part. Before starting, you’ll need to understand and sign a consent form, which explains everything about the study.
For women, you must either have had specific surgeries that prevent pregnancy, or have gone through menopause at least a year ago. If you could still become pregnant, you'll need to agree to use effective contraception for one week after each special scan. For men, if your partner could become pregnant, you'll need to use effective contraception for 90 days after each scan, and men also cannot donate sperm for 90 days after the scan.
If you are taking medication for conditions like multiple myeloma, heart problems, or tafamides, your dosage must be stable. The researchers will also check other health factors to ensure the study is safe and appropriate for you.
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 40 years old or older?
- Can you understand and sign a consent form?
- If you're a woman, are you post-menopausal or surgically sterile?
- If not, are you willing to use effective contraception for a week after the scan?
- If you're a man, are you willing to use effective contraception with your partner for 90 days after the scan, and not donate sperm?
- Are your existing medications for relevant conditions on a stable dosage?
What does participation involve?
If you decide to join this study, you will have a special type of scan called a PET scan. This scan involves a small, safe injection of a tracer substance called Florbetaben F18, which helps doctors see what's happening in your heart. You will have this scan performed twice to check if the results are consistent. The study will also involve blood tests to measure certain substances. Researchers may also compare the scan results with other ways of measuring things in your heart, if appropriate. The exact number of visits and the total duration aren't fully detailed here, but generally, a test-retest study would involve at least two visits for the scans and possibly follow-up for blood tests. You will be told the precise schedule during the consent process.
Potential risks and benefits
Locations (2)
- Royal Free HospitalVerified postcodeLondon, United Kingdom· Recruiting
- King's College LondonVerified postcodeLondon, United Kingdom· Recruiting
Common questions
What is cardiac amyloidosis?
It's a condition where abnormal protein deposits build up in the heart, making it harder for it to work properly.
What is a PET scan?
It's a medical imaging test that uses a special substance to show how your organs and tissues are working.
Why will I have the scan twice?
Having the scan twice helps researchers check if the results are reliable and consistent each time it's performed.
Is the substance used in the scan safe?
Yes, Florbetaben F18 is a safe, traceable substance used in small amounts during the PET scan.
Will I get my results from the scan?
Details on receiving individual results are usually discussed during the consent process. The study aims to gather overall information, not necessarily provide personal diagnostic results for immediate care.
How to find out more
Iris Hardewig, Dr
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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