ClinicalTrials.gov record NCT07154381

Hybrid Florbetaben PET/MRI for Imaging of Cardiac Amyloidosis

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 23, 2026

Monocentric Observational Trial for Florbetaben PET/MRI Hybrid Imaging in Patients With Cardiac Amyloidosis

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age40 years old and older
SexAll
LocationGermany
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This observational study uses hybrid 18F-Florbetaben PET/MRI scans in people with cardiac amyloidosis. Researchers will compare PET, MRI, and echocardiography measures and follow participants for major adverse cardiac events (MACE) for 36 months. The goal is to identify imaging markers that relate to prognosis.

What it is studying. The study is testing whether measurements from 18F-Florbetaben PET/MRI—including PET parameters such as standardized uptake value (SUV), retention index and visual positivity—are associated with future major adverse cardiac events (MACE). It will also compare PET findings with cardiac MRI measures (for example late gadolinium enhancement, extracellular volume, native T1 mapping) and common echocardiography markers to see which imaging parameters relate to outcomes.

What the researchers hope to learn. To determine whether PET-based measures (SUV, retention index, washout, visual positivity) predict MACE; to define optimal PET thresholds by ROC analysis; to calculate hazard ratios for PET parameters; and to compare PET, MRI, and echocardiography parameters as prognostic markers.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

Exploration of prognostic parameters in 18F-Florbetaben PET/MRI in patients with cardiac amyloidosis. The clinical endpoints are defined as occurence of major adverse cardiac events (MACE) in amyloidosis patients. Additionally, MACE outcome stratified by PET parameters will be evaluated and individual parameters of the imaging techniques will be compared to each other (PET, MRI or echocardiography).

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Age > 40 years
  • proven Amyloidosis (ATTR or AL)
  • Women: negative pregnancy test less than weeks prior imaging.

Exclusion criteria

  • Patients receiving amyloidosis-specific treatment prior study inclusion.
  • Patients participating in other clinical trails for treatment of Amyloidosis.
  • Pregnancy
  • Contraindiactions for MRI (eGFR<30ml/min/1.73m2; gadolinium allergy; metallic implants or device not suited for 3T MRI).
  • inability of consent
  • Refusal of consent

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

The aim of the study is to investigate the value of hybdrid imaging using 18F-Florbetaben PET/MRI for detecting prognostically relevant disease markers in patients with cardiac amyloidosis. The clinical endpoints are defined as occurence of major adverse cardiac events (e.g. hospitalizations due to heart failure, cardiovascular mortality, implantation of cardioverters etc.) in PET positive and negative patients. Additionally, MACE outcome stratified by PET parameters will be evaluated and individual parameters of the imaging techniques will be compared to each other. CMR imaging will focused on LGE presence, ECV, native T1 mapping and echocardiography on commonly used markers includiging EF, Strain, E/e' and other functional parameters.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will undergo a hybrid 18F-Florbetaben PET/MRI scan as part of diagnostic work-up; cardiac MRI sequences described include late gadolinium enhancement (LGE), extracellular volume (ECV), and native T1 mapping (gadolinium contrast may be used). Their imaging will be compared with other cardiac measures (for example echocardiography) and analyzed. Study staff will follow clinical outcomes for up to 36 months to record major adverse cardiac events (MACE). No investigational treatment is assigned by the study; participation requires informed consent.

How the study is structured. A prospective, single-center observational cohort: people with proven cardiac amyloidosis have a Florbetaben PET/MRI scan (as part of diagnostic workup) and are followed for clinical outcomes for up to 36 months. No experimental treatments are assigned.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in Germany. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on ATTRv amyloidosis

This trial is also listed on this site under wild-type ATTR amyloidosis.

Clinical trials106 trials listed for ATTRv amyloidosisEvery trial the registry lists for ATTRv amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in ATTRv amyloidosis researchLatest monthly update: September 2026. Includes: Gene-silencing drugs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Dec 9, 2019
Primary completion
October 2025 (estimated)
Study completion
December 2025 (estimated)
Target enrollment
25 participants (estimated)
Last updated on registry
Sep 4, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
University Hospital, Essen

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

PET/MRI
A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
endpoints
Something the study measures to judge its results, such as a symptom score, a blood test or survival. Outcomes are grouped as primary, secondary and sometimes exploratory.
stratified
Randomisation done separately within subgroups, such as age bands or disease severity, so that each group contains a similar mix.
MRI
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
echocardiography
An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
eGFR
A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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