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NCT Number: NCT07154381

Hybrid Florbetaben PET/MRI for Imaging of Cardiac Amyloidosis

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).

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Key information

Conditions

Cardiac Amyloidosis Amyloid Neuropathies Amyloid Neuropathies, Familial Amyloidosis Amyloidosis, Familial Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Metabolic Diseases Metabolism, Inborn Errors Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Peripheral Nervous System Diseases Proteostasis Deficiencies

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Nuclear medicine, University Hospital Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location status: Recruiting

Location contact

David Kersting, MD, PhD

CONTACT

[email protected]

+49 2017232073

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Occurence of MACE

    Time frame: 36 Months

    Occurence of MACE, MACE defined as All-cause of Death or Hospitalization due to heart failure, implantation of a cardioverter defibrillator or other urgent cardiovascular intervention.

Secondary outcomes

  1. MACE free survival by optimal tracer retention index for MACE

    Time frame: 36 Months

    MACE free survival by optimal tracer retention index (RI), threshold defined by ROC analysis for prediction of MACE.

  2. MACE free survival by optimal SUV threshold for MACE

    Time frame: 36 Months

    MACE free survival by optimal standardized uptake value (SUV), threshold defined by ROC analysis for prediction of MACE.

  3. MACE free survival by optimal retention index for AL-Amyloidosis

    Time frame: 36 Months

    MACE free survival by optimal SUV, threshold defined by ROC analysis for prediction of AL-Amyloidosis.

  4. MACE free survival by optimal PET based threshold for AL-Amyloidosis

    Time frame: 36 Months

    MACE free survival by optimal tracer retention index (RI) defined by ROC analysis for prediction of AL-Amyloidosis.

  5. Hazard Ratios for SUV

    Time frame: 36 Months

    Hazard Ratios for SUV PET parameters by univariate regression analysis

  6. Hazard Ratios for retention index

    Time frame: 36 Months

    Hazard Ratios for tracer retention index by univariate regression analysis

  7. Hazard Ratios for tracer washout

    Time frame: 36 Months

    Hazard Ratios for tracer washout by univariate regression analysis

  8. Hazard Ratios for visual PET positivity

    Time frame: 36 Months

    Hazard Ratios for visual PET positivity defined by clear higher-than-background tracer uptake at 40-60 min post. injection.

Study contacts

Contact information is provided by the study sponsor or research team.

David Kersting, MD, PhD

CONTACT

[email protected]

+492017232073

Lukas Kessler, MD

CONTACT

[email protected]

+492017232073

Sponsors and collaborators

Lead sponsor

University Hospital, Essen

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Sep 4, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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