Hybrid Florbetaben PET/MRI for Imaging of Cardiac Amyloidosis

University Hospital Essen

Status: Enrolling

Conditions: Cardiac Amyloidosis

Study type: Observational

Funder types: Other

Identifiers

NCT07154381

19-8798-BO

Details and patient eligibility

About

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).

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

25 participants in 1 patient group

Amyloidosis

Description:

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