Hybrid Florbetaben PET/MRI Scans to Study Heart Amyloidosis Patients
Studies whether a florbetaben PET/MRI scan predicts heart problems in people with heart amyloidosis.
Key facts
- Who runs it
- University Hospital, Essen
- Where
- Essen, GermanySee the site
- Trial code
- Registry title
- Hybrid Florbetaben PET/MRI for Imaging of Cardiac Amyloidosis
- Status
- Recruiting
- People taking part
- 25 people, planned
- Started
- 9 Dec 2019
- Planned end
- Dec 2025
- Type of study
- Observational
- Record updated
- 4 September 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults over 40 with proven cardiac amyloidosis (ATTR or AL) who have not yet started amyloidosis-specific treatment. It studies a florbetaben PET/MRI scan of the heart.
- Age
- Older than 40 years
- Sex
- All sexes can join. Women need a negative pregnancy test before the scan.
- Disease stage
- Proven amyloidosis, either ATTR or AL type
- Earlier treatment
- Cannot have received amyloidosis-specific treatment before joining
Main reasons for not taking part
- Amyloidosis-specific treatment before joining
- Taking part in another trial for amyloidosis treatment
- Pregnancy
- Reasons the MRI cannot be done: eGFR<30ml/min/1.73m2, gadolinium allergy, metal implants or devices not suited for 3T MRI
- Unable or unwilling to give consent
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- Age > 40 years
- proven Amyloidosis (ATTR or AL)
- Women: negative pregnancy test less than weeks prior imaging
Who cannot take part
- Patients receiving amyloidosis-specific treatment prior study inclusion
- Contraindiactions for MRI (eGFR<30ml/min/1.73m2; gadolinium allergy; metallic implants or device not suited for 3T MRI)
- Patients participating in other clinical trails for treatment of Amyloidosis
- Pregnancy
- inability of consent
- Refusal of consent
Where in Germany
- Department of Nuclear medicine, University Hospital EssenEssen, GermanyContact: David Kersting, MD, PhDTaking people
About the trial
What the trial wants to find out
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).
The group in the trial
- Amyloidosis
Oberservation of patients with proven cardiac amyloidosis and Florbetaben PET/MRI as part of diagnostic work up
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Monocentric Observational Trial for Florbetaben PET/MRI Hybrid Imaging in Patients With Cardiac Amyloidosis
- Plain-language title
- Hybrid Florbetaben PET/MRI Scans to Study Heart Amyloidosis PatientsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 4 September 2025