Hybrid Florbetaben PET/MRI for Imaging of Cardiac Amyloidosis

NCT ID: NCT07154381

Last Updated: 2025-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-09

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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Cardiac Amyloidosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Amyloidosis

Oberservation of patients with proven cardiac amyloidosis and Florbetaben PET/MRI as part of diagnostic work up

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Essen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Nuclear medicine, University Hospital Essen

Essen, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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David Kersting, MD, PhD

Role: CONTACT

+492017232073

Lukas Kessler, MD

Role: CONTACT

+492017232073

Facility Contacts

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David Kersting, MD, PhD

Role: primary

+49 2017232073

Other Identifiers

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19-8798-BO

Identifier Type: -

Identifier Source: org_study_id

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