Study to Diagnose Cardiac Amyloidosis in Patients with Monoclonal Component Using Florbetaben (18F) PET-CT

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What is this study about?

This clinical trial is focused on studying a condition known as cardiac amyloidosis, specifically a type called AL amyloidosis. This disease occurs when abnormal proteins, called amyloids, build up in the heart tissue, affecting its function. The study will use a special imaging technique called positron emission tomography/computed tomography (PET-CT) with a substance known as 18F-florbetaben. This technique helps to visualize the heart and detect amyloid deposits without needing invasive procedures.

The purpose of the study is to compare two methods of diagnosing AL amyloidosis: the traditional invasive method and a new non-invasive method using PET-CT with 18F-florbetaben. Participants will undergo the PET-CT scan, and the results will be compared to the traditional diagnostic approach to see how well the new method works. The study will also look at how the intensity of amyloid deposits changes over time and assess the safety of the PET-CT procedure.

Participants will receive an injection of Neuraceq, which contains 18F-florbetaben, and then undergo the PET-CT scan. The study will monitor participants for any side effects during and after the imaging procedure. The trial aims to provide a clearer, less invasive way to diagnose cardiac amyloidosis, potentially improving the diagnosis and management of this condition.

1 initial assessment

The study involves a non-invasive diagnostic method for cardiac amyloidosis using a special imaging technique called PET-CT with a substance known as 18F-florbetaben.

Participants must be over 18 years old and able to understand and sign the consent form.

Certain medical criteria must be met, such as specific blood test results and heart measurements.

2 imaging procedure

The main procedure involves an injection of Neuraceq 300 MBq/mL solution, which contains 18F-florbetaben, administered through a vein.

This is followed by a PET-CT scan to visualize the heart and assess for signs of amyloidosis.

The procedure is designed to be non-invasive, meaning it does not require surgery or entering the body beyond the injection.

3 follow-up and monitoring

Participants will be monitored for any side effects or adverse reactions during and after the imaging procedure.

The study will track changes in the heart’s uptake of 18F-florbetaben over a period of 12 months.

Safety and tolerability of the procedure will be assessed, focusing on any immediate or short-term effects.

4 completion of study

The study is expected to conclude by February 28, 2025.

Results will be analyzed to compare the effectiveness of the non-invasive imaging method against traditional diagnostic methods.

Who Can Join the Study?

Men and women who are older than 18 years can participate.
Participants must be able to understand, sign, and date the informed consent form. This means they need to agree to join the study and understand what it involves.
Participants should have certain heart-related measurements. These include:
- NT-proBNP values greater than 332 ng/L, which is a blood test that helps check heart function, but only if they do not have kidney problems or a heart rhythm issue called atrial fibrillation.
- Left ventricular mean wall thickness greater than 12 mm on an echocardiogram, which is an ultrasound test that looks at the heart’s structure.
- A pattern of circumferential or diffuse subendocardial late gadolinium enhancement, which is a specific finding on a heart MRI scan.
- BNP greater than 81 ng/L, another blood test related to heart function.
The clinical setting should be judged compatible with cardiac amyloidosis by experienced clinicians. This means doctors who know about this condition should agree that the participant’s symptoms and test results fit with this diagnosis.

Who Cannot Join the Study?

Patients with cardiac amyloidosis cannot participate. This is a condition where abnormal proteins build up in the heart, affecting its function.
Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
Patients who do not have a monoclonal component cannot participate. This refers to a specific type of protein in the blood that is often associated with certain diseases.
Patients who are not able to undergo the required tests, such as PET/CT scans, cannot participate. These are imaging tests that help doctors see inside the body.
Patients who are part of a vulnerable population, such as those with certain health conditions or who are unable to give consent, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country
Azienda Sanitaria Universitaria Giuliano Isontina	Trieste	Italy
Fondazione Toscana Gabriele Monasterio	Pisa	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Universita’ Degli Studi Di Ferrara	Ferrara	Italy
Ajexyii Ofetkjwvmuz Pcso Gdakxphe Xtsbs	Bergamo	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	01.12.2022

Trial locations

Investigated drugs:

Florbetaben (18F)

18F-florbetaben is a special imaging agent used in PET-CT scans. In this study, it helps doctors see if there is a buildup of certain proteins in the heart, which can be a sign of a condition called cardiac AL amyloidosis. This imaging agent allows for a non-invasive way to diagnose the condition, meaning it doesn’t require surgery or other invasive procedures.

Investigated diseases:

Cardiac amyloidosis

Cardiac Amyloidosis – Cardiac amyloidosis is a condition where abnormal protein deposits, known as amyloid, accumulate in the heart tissue. This buildup can cause the heart walls to become stiff, affecting the heart’s ability to pump blood effectively. Over time, this can lead to symptoms such as fatigue, shortness of breath, and swelling in the legs and ankles. The disease can progress slowly or rapidly, depending on the type of amyloid protein involved. It is often associated with other systemic symptoms due to amyloid deposits in other organs. The condition is considered rare and can be challenging to diagnose without specialized tests.

Trial ID:

2024-517942-33-03

Protocol code:

PETAL

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study to Diagnose Cardiac Amyloidosis in Patients with Monoclonal Component Using Florbetaben (18F) PET-CT

What is this study about?

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