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Study on the Use of Florbetaben (18F) PET Imaging for Diagnosing Cardiac AL 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 a condition known as Cardiac Amyloidosis, which is a heart-related disease caused by the buildup of abnormal proteins called amyloids in the heart tissue. The study also includes a specific type of this condition called AL Amyloidosis. The trial will use a special imaging technique called Positron Emission Tomography (PET) with a substance known as [18F]florbetaben. This substance is injected into the body and helps to create detailed images of the heart, which can assist doctors in diagnosing the disease.

The purpose of the study is to evaluate how effective and safe the [18F]florbetaben PET imaging is in diagnosing Cardiac AL Amyloidosis. Participants in the study will undergo this imaging process, which involves receiving an injection of the [18F]florbetaben solution. The study aims to determine how accurately this imaging method can identify the presence of the disease compared to the standard clinical diagnosis methods currently in use.

Throughout the study, participants will have their heart images taken using the PET scan, and these images will be visually assessed by medical professionals. The study will also explore how the results from the PET scans correlate with other heart function measurements, such as the heart's pumping ability and the size of the heart muscle. The findings from this study could potentially improve the way Cardiac Amyloidosis is diagnosed and managed in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial consent and eligibility

    Upon joining the study, you will be required to provide written informed consent. This means you will sign a document that explains the study and confirms your willingness to participate.

    You must meet certain criteria to be eligible for the study. These include being at least 18 years old and having specific medical conditions related to cardiac amyloidosis.

  2. Step 2

    Preparation for PET scan

    Before the PET scan, you may undergo diagnostic procedures to confirm cardiac involvement. These could include biopsies or imaging tests like echocardiography or cardiac magnetic resonance imaging.

    Female participants of childbearing potential must use effective contraception for one week after the PET scan. Male participants and their partners must use effective contraception for 90 days after the scan.

  3. Step 3

    Administration of Neuraceq

    You will receive an injection of Neuraceq, which contains the active substance florbetaben (18F). This is a solution specifically used for PET imaging.

    The injection is administered to help visualize cardiac amyloidosis during the PET scan.

  4. Step 4

    PET scan procedure

    After the injection, you will undergo a PET scan. This imaging test helps in diagnosing cardiac amyloidosis by providing detailed images of your heart.

    The scan will assess the presence of amyloid deposits in your heart tissue.

  5. Step 5

    Post-scan follow-up

    Following the PET scan, your results will be analyzed to determine the sensitivity and specificity of the imaging in diagnosing cardiac amyloidosis.

    You may be asked to complete questionnaires to assess the impact of the PET imaging on your diagnosis and management.

Who can join the trial?

13 criteria

  • Participants must be 18 years or older.
  • Participants must be able to understand, sign, and date a written consent form.
  • Participants must provide written consent before any study-related assessments are done.
  • Participants should be considered for a possible diagnosis of cardiac amyloidosis (a condition affecting the heart) if they have one of the following:
    • Systemic amyloidosis (a condition where abnormal protein builds up in organs) without proven heart involvement.
    • Known plasma cell disorders like MGUS or multiple myeloma.
    • Abnormal free light chain levels in urine or blood.
    • Heart failure with preserved ejection fraction (a type of heart failure where the heart pumps normally but is stiff).
    • Participants must also have one of the following signs of heart involvement:
      • Heart wall thickness greater than 12mm as measured by an ultrasound, without other known causes of thickening.
      • NT-proBNP level greater than 335 ng/L (a blood test indicating heart stress).
      • Participants must have planned diagnostic procedures to confirm the diagnosis and heart involvement, such as a heart biopsy or imaging tests.
      • Female participants must be either surgically sterile or post-menopausal for at least 1 year. If they can have children, they must use a highly effective birth control method for one week after the PET scan.
      • Male participants and their partners who can have children must use a highly effective birth control method for at least 90 days after each PET scan.
      • Male participants must agree not to donate sperm for at least 90 days after the PET scan.

Who cannot join the trial?

3 criteria

  • Patients with any other type of amyloidosis not specified in the study.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

[18F]florbetaben is a special type of imaging agent used in a PET scan, which is a kind of medical imaging test. In this clinical trial, it helps doctors see if there are any unusual protein deposits in the heart, which can be a sign of a condition called cardiac AL amyloidosis. This imaging agent works by highlighting these protein deposits, making them visible on the PET scan, so doctors can better diagnose the condition. The goal is to see how well this imaging agent can help in accurately diagnosing cardiac AL amyloidosis compared to the usual methods doctors use.

What is already known about the treatment

[18F]florbetaben – [18F]florbetaben is administered through an injection and is used in Positron Emission Tomography (PET) imaging to help diagnose cardiac AL amyloidosis. It is currently being studied in a Phase 3 clinical trial to assess its effectiveness and safety for this purpose. The main therapeutic indication is to aid in the diagnosis of cardiac AL amyloidosis, a condition where abnormal protein deposits affect the heart. At the molecular level, [18F]florbetaben binds to amyloid deposits, allowing them to be visualized in PET scans. It is classified as a radiopharmaceutical used in diagnostic imaging.

Investigated diseases

  • AL Amyloidosis

    AL Amyloidosis is a disease where abnormal protein deposits, known as amyloid, accumulate in tissues and organs. These proteins are light chains produced by plasma cells. The disease often affects the kidneys, heart, liver, and nerves. As amyloid builds up, it disrupts normal organ function. Over time, this can lead to organ damage. The progression varies depending on the organs involved and the amount of amyloid deposited.

  • Cardiac Amyloidosis

    Cardiac Amyloidosis is a condition where amyloid proteins are deposited in the heart tissue. This leads to the thickening and stiffening of the heart walls. As the disease progresses, the heart's ability to pump blood effectively is compromised. This can result in symptoms like fatigue, shortness of breath, and irregular heartbeats. The progression of the disease can lead to heart failure if not managed. The severity and speed of progression can vary among individuals.

  • ATTR Amyloidosis

    ATTR Amyloidosis is characterized by the accumulation of transthyretin amyloid proteins in various organs. This condition can be hereditary or acquired. The amyloid deposits primarily affect the heart and nervous system. As the disease progresses, it can lead to heart problems and nerve damage. Symptoms may include heart failure, neuropathy, and autonomic dysfunction. The rate of progression can differ based on genetic factors and the organs involved.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-500186-27-00Protocol codeFBB-02-01-21aEstimated enrolment260 patientsSponsorLantheus Germany GmbH

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