RecruitingPhase 3NCT05184088

Efficacy of [18F]Florbetaben PET for Diagnosis of Cardiac AL Amyloidosis

An Open-label, Multi-center, Non-randomized Pivotal Phase 3 Study to Evaluate the Efficacy and Safety of [18F]Florbetaben Positron Emission Tomography (PET) Imaging to Diagnose Cardiac AL Amyloidosis


Sponsor

Life Molecular Imaging GmbH

Enrollment

200 participants

Start Date

Jan 13, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open-label, multi-center pivotal Phase 3 study to visually and quantitatively assess PET images obtained after single application of 300 MBq \[18F\]florbetaben and PET scanning of patients with suspected cardiac amyloidosis.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a PET scan imaging agent called [18F]Florbetaben to see whether it can accurately detect cardiac AL amyloidosis — a dangerous condition where abnormal proteins called amyloids build up in the heart muscle, stiffening it and causing heart failure. Currently, diagnosing this condition often requires an invasive heart biopsy; this study aims to see if a PET scan can be just as accurate without the need for surgery. You may be eligible if: - You are 18 years or older - You are being evaluated for possible cardiac amyloidosis - You have at least one of the following: established systemic amyloidosis, known plasma cell dyscrasia (such as MGUS or myeloma), abnormal free light chains in urine or blood, or heart failure with preserved ejection fraction - AND at least one cardiac sign: thickened heart walls on echocardiogram or elevated NT-proBNP/BNP levels - You are scheduled for a diagnostic procedure to confirm the diagnosis You may NOT be eligible if: - You have a known allergy to the study drug - You have severe liver disease - You are unable to lie flat for up to 60 minutes - You are pregnant, breastfeeding, or lactating - You have had a radiopharmaceutical injection within the past 10 half-lives Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG[18F]florbetaben

All enrolled patients will undergo \[18F\]florbetaben PET imaging.


Locations(14)

St Luke's Hospital

Kansas City, Kansas, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

University of Augsburg

Augsburg, Germany

Charite Berlin

Berlin, Germany

University of Essen

Essen, Germany

HOPA Hamburg

Hamburg, Germany

University of Heidelberg

Heidelberg, Germany

University of Würzburg

Würzburg, Germany

Hospital University Bellvitge

Barcelona, Spain

Hospital University Puerta de Hierro

Madrid, Spain

Clínica Universidad de Navarra

Pamplona, Spain

University of Salamanca

Salamanca, Spain

Royal Free Hospital

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05184088


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