Hybrid Florbetaben PET/MRI for Imaging of Cardiac Amyloidosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cardiac Amyloidosis. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Monocentric Observational Trial for Florbetaben PET/MRI Hybrid Imaging in Patients With Cardiac Amyloidosis
Overview
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).
Detailed description
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.
Primary outcome measures
- Occurence of MACE [Time frame: 36 Months]
Secondary outcome measures (8)
- MACE free survival by optimal tracer retention index for MACE [Time frame: 36 Months]
- MACE free survival by optimal SUV threshold for MACE [Time frame: 36 Months]
- MACE free survival by optimal retention index for AL-Amyloidosis [Time frame: 36 Months]
- MACE free survival by optimal PET based threshold for AL-Amyloidosis [Time frame: 36 Months]
- Hazard Ratios for SUV [Time frame: 36 Months]
- Hazard Ratios for retention index [Time frame: 36 Months]
- Hazard Ratios for tracer washout [Time frame: 36 Months]
- Hazard Ratios for visual PET positivity [Time frame: 36 Months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Department of Nuclear medicine, University Hospital Essen — Essen
Identifiers
NCT: NCT07154381 · 19-8798-BO