Cardiac AmyloidosisNCT07154381
Hybrid Florbetaben PET/MRI for Imaging of Cardiac Amyloidosis
An observational study of Cardiac Amyloidosis, run by University Hospital, Essen at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cardiac Amyloidosis
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- 9 Dec 2019to Dec 2025
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with proven amyloidosis with no competing amyloidosis treatments, willing and capable of undergoing Florbetaben PET/MRI.
Who may be able to join
- Age > 40 years
- proven Amyloidosis (ATTR or AL)
- Women: negative pregnancy test less than weeks prior imaging.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Nuclear medicine, University Hospital Essen
Essen, North Rhine-Westphalia, 45147
David Kersting, MD, PhD, +49 2017232073, david.kersting@uk-essen.de
About this study
Official title: Monocentric Observational Trial for Florbetaben PET/MRI Hybrid Imaging in Patients With 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).
Read the 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.
- Conditions
- Cardiac Amyloidosis
- Keywords
- PET/MRI, Florbetaben
- Medical subject headings
- Amyloid Neuropathies, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Amyloidosis | Oberservation of patients with proven cardiac amyloidosis and Florbetaben PET/MRI as part of diagnostic work up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of MACE
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.
Measured: 36 Months
Secondary outcomes (8)
MACE free survival by optimal tracer retention index for MACE
MACE free survival by optimal tracer retention index (RI), threshold defined by ROC analysis for prediction of MACE.
Measured: 36 Months
MACE free survival by optimal SUV threshold for MACE
MACE free survival by optimal standardized uptake value (SUV), threshold defined by ROC analysis for prediction of MACE.
Measured: 36 Months
MACE free survival by optimal retention index for AL-Amyloidosis
MACE free survival by optimal SUV, threshold defined by ROC analysis for prediction of AL-Amyloidosis.
Measured: 36 Months
MACE free survival by optimal PET based threshold for AL-Amyloidosis
MACE free survival by optimal tracer retention index (RI) defined by ROC analysis for prediction of AL-Amyloidosis.
Measured: 36 Months
Hazard Ratios for SUV
Hazard Ratios for SUV PET parameters by univariate regression analysis
Measured: 36 Months
Hazard Ratios for retention index
Hazard Ratios for tracer retention index by univariate regression analysis
Measured: 36 Months
Hazard Ratios for tracer washout
Hazard Ratios for tracer washout by univariate regression analysis
Measured: 36 Months
Hazard Ratios for visual PET positivity
Hazard Ratios for visual PET positivity defined by clear higher-than-background tracer uptake at 40-60 min post. injection.
Measured: 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start9 Dec 2019
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac AmyloidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154381
- Sponsor's protocol ID
- 19-8798-BO
- Status last verified
- May 2025
- First submitted
- 20 May 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric Observational Trial for Florbetaben PET/MRI Hybrid Imaging in Patients With Cardiac Amyloidosis
- ClinicalTrials.gov ID
- NCT07154381
- Acronym / sponsor ID
- 19-8798-BO
- Conditions
- Cardiac Amyloidosis
- Keywords
- PET/MRI, Florbetaben
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amyloidosis | – | –Oberservation of patients with proven cardiac amyloidosis and Florbetaben PET/MRI as part of diagnostic work up |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with proven amyloidosis with no competing amyloidosis treatments, willing and capable of undergoing Florbetaben PET/MRI.
Key inclusion criteria (3 listed)
- Age > 40 years
- proven Amyloidosis (ATTR or AL)
- Women: negative pregnancy test less than weeks prior imaging.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Amyloidosis, run by University Hospital, Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Kersting, MD, PhD (+492017232073, david.kersting@uk-essen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurence of MACE (time frame: 36 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.