RecruitingPhase 1NCT06790394

Test-retest Study With [18F]FBB in Cardiac Amyloidosis

A Test-retest Study to Evaluate the Reproducibility of [18F]Florbetaben PET Imaging in Patients With Cardiac Amyloidosis and Control Patients

Sponsor

Lantheus Germany GmbH

Enrollment

15 participants

Start Date

Oct 21, 2025

Study Type

INTERVENTIONAL

Conditions

Cardiac Amyloidosis

Summary

This study is an open-label study to evaluate and characterize test-retest reliability of \[18F\]florbetaben PET in subjects with AL-CA and ATTR-CA compared to non-CA subjects. Quantification of the \[18F\]florbetaben parameters related to the deposition of amyloid in the heart (such as Myocardial Tracer Retention (MTR) or Retention Index (RI)), and the variability in these parameters after repeated imaging will be evaluated. Measurement of blood metabolites and comparison of invasive with non-invasive quantification of \[18F\]florbetaben uptake in the heart will be performed.

Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Florbetaben F18 for people with cardiac amyloidosis. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 40 Years and older.

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

DRUGFlorbetaben F18

Florbetaben F18 is a radioactive diagnostic agent being developed for the indication of PET imaging of the heart to detect amyloid pathology. All patients will receive two administrations of Florbetaben F18 at a radioactive dose of 300 megabecquerel (MBq).