Not recruitingRare disease

Study on the Use of Flutemetamol (18F) for Diagnosing Cardiac Amyloidosis in Patients

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying cardiac amyloidosis, a condition where abnormal protein deposits, known as amyloid, build up in the heart tissue. The study will use a special imaging agent called Vizamyl, which contains the active substance Flutemetamol (18F). This agent is injected into the body and helps doctors see the amyloid deposits in the heart using a type of scan called PET (Positron Emission Tomography).

The purpose of the study is to evaluate how well Flutemetamol (18F) can detect amyloid deposits in patients with different types of cardiac amyloidosis, including ATTRwt, ATTRv, and AL. During the study, participants will receive an injection of Vizamyl and undergo a PET scan to measure the uptake of the tracer in the heart. This will help researchers understand how the tracer interacts with amyloid deposits and whether it can effectively identify the presence and extent of the disease.

The study will also compare the results in patients with different genetic types of cardiac amyloidosis and those with other heart conditions. By doing so, researchers aim to improve the diagnosis and understanding of cardiac amyloidosis, potentially leading to better treatment options in the future. Participants will be monitored throughout the study to ensure their safety and to gather valuable data on the effectiveness of the imaging agent.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after meeting specific criteria, including a diagnosis of cardiac amyloidosis or non-infiltrative left ventricular hypertrophy. Eligibility is determined through various medical examinations and tests.
Consent is required to participate in the study.
Step 2
Initial assessment
An initial assessment is conducted to confirm the diagnosis and gather baseline data. This may include cardiac examinations, biomarker assays, and imaging tests such as EKG and echocardiography.
Step 3
Administration of tracer
The tracer flutemetamol (18F) is administered intravenously. This is a solution for injection known as Vizamyl 400 MBq/mL.
The purpose of the tracer is to evaluate its affinity for cardiac amyloid deposits.
Step 4
PET scan
A PET scan is performed to measure the uptake of the tracer in the heart. This helps in assessing the presence and extent of amyloid deposits.
The scan provides quantitative data on myocardial uptake, which is crucial for the study's objectives.
Step 5
Follow-up assessments
Follow-up assessments may be conducted to monitor the tracer's uptake over time and to gather additional data.
These assessments help in understanding the progression of cardiac amyloidosis and the effectiveness of the tracer.
Step 6
Completion of study
The study is expected to conclude by July 31, 2025. Participants will be informed about the outcomes and any relevant findings related to their health condition.

Who can join the trial?

12 criteria

Must be a male or female aged 18 years or older.
Must have been diagnosed with **cardiac amyloidosis**. This is a condition where abnormal proteins build up in the heart.
Must have a clinical suspicion of the disease based on one or more of the following exams:
- Cardiac examination
- Biomarker assay, which includes tests like NT-proBNP, HS-TnT, plasma protein electrophoresis, serum and urinary immunofixation, and free light chains. These are tests that help check for certain proteins in the blood or urine.
- Baseline EKG, which is a test that checks the heart's electrical activity.
- Baseline echocardiography, which is an ultrasound of the heart.
- Cardiac magnetic resonance, which is an imaging test to look at the heart.
- Must have a clearly positive **osteophilic radiopharmaceutical scintigraphy** (Perugini 2-3) without a serum or urinary monoclonal component. This is a special imaging test that shows certain deposits in the body.
- Alternatively, must have an abdominal fat biopsy or endomyocardial biopsy showing ATTR or AL amyloidosis. These are tests where a small sample of tissue is taken to check for the disease.
- Must have genetic characterization to identify patients with **ATTRv**. This means a genetic test to find a specific type of amyloidosis.
- Must be able to provide consent to participate in the study.
- Control subjects must be diagnosed with non-infiltrative left ventricular hypertrophy. This is a condition where the heart's left ventricle is thicker than normal but not due to amyloidosis.

Who cannot join the trial?

6 criteria

Patients with other types of heart conditions that are not related to **cardiac amyloidosis** cannot participate. **Cardiac amyloidosis** is a condition where abnormal proteins build up in the heart.
Patients who are not within the specified age range for the study cannot participate. The study is looking for specific age groups.
Patients who are not able to give informed consent or understand the study details cannot participate. This means they need to fully understand what the study involves and agree to take part.
Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of both the mother and the baby.
Patients who have participated in another clinical trial recently may not be eligible. This is to avoid any interference with the results of the study.
Patients with certain medical conditions that could interfere with the study results cannot participate. This is to ensure the study results are accurate and reliable.

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Verified sites

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Fondazione Toscana Gabriele Monasterio
Verified
Pisa, Italy

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Investigated drugs

Vizamyl: This is a tracer used in PET scans to help doctors see certain types of deposits in the body. In this study, it is being used to detect amyloid deposits in the heart of patients with cardiac amyloidosis. The goal is to see how well this tracer can identify these deposits, which can help in diagnosing the condition.

Flutemetamol (18F)

What is already known about the treatment

Vizamyl – Vizamyl is administered as an intravenous injection and is used in the form of a tracer for PET scans. It is currently being explored in clinical trials for its diagnostic potential in cardiac amyloidosis. The main therapeutic indication is to help visualize amyloid deposits in the heart, which can aid in diagnosing different types of cardiac amyloidosis. At the molecular level, Vizamyl binds to amyloid plaques, allowing them to be detected through imaging. It is classified as a radiopharmaceutical diagnostic agent.

Investigated diseases

Cardiac Amyloidosis – Cardiac amyloidosis is a condition where abnormal protein deposits, known as amyloid, accumulate in the heart tissue. This buildup can lead to the heart becoming stiff, which affects its ability to pump blood effectively. There are different types of cardiac amyloidosis, including ATTRwt (wild-type transthyretin amyloidosis), ATTRv (variant transthyretin amyloidosis), and AL (light chain amyloidosis). Each type is characterized by the specific protein that forms the amyloid deposits. Over time, the heart's function may be increasingly compromised as the amyloid deposits grow. This can result in symptoms such as fatigue, shortness of breath, and swelling in the legs.