Hybrid Florbetaben PET/MRI for Imaging of Cardiac Amyloidosis

NCT07154381 | Recruiting

• 1 other identifier: 19-8798-BO
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Cardiac Amyloidosis

Keywords

PET/MRI; Florbetaben

Outcome Measures

Primary Outcomes (1)

• 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.

  36 Months

Secondary Outcomes (8)

• MACE free survival by optimal tracer retention index for MACE

  36 Months

• MACE free survival by optimal SUV threshold for MACE

  36 Months

• MACE free survival by optimal retention index for AL-Amyloidosis

  36 Months

• MACE free survival by optimal PET based threshold for AL-Amyloidosis

  36 Months

• Hazard Ratios for SUV

  36 Months

Study Arms (1)

Amyloidosis

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

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with proven amyloidosis with no competing amyloidosis treatments, willing and capable of undergoing Florbetaben PET/MRI.

You may qualify if:

• Age \> 40 years
• proven Amyloidosis (ATTR or AL)
• Women: negative pregnancy test less than weeks prior imaging.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Essen: lead

Study Sites (1)

Department of Nuclear medicine, University Hospital Essen

Essen, North Rhine-Westphalia, 45147, Germany

RECRUITING

MeSH Terms

Conditions

Amyloid Neuropathies, Familial

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies

Central Study Contacts

David Kersting, MD, PhD

CONTACT

+492017232073; david.kersting@uk-essen.de

Lukas Kessler, MD

CONTACT

+492017232073; lukas.kessler@uk-essen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: September 4, 2025
• Study Start: December 9, 2019
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)