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RECRUITING
NCT06790394
PHASE1

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

Sponsor: Life Molecular Imaging GmbH

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2025-10-21

Completion Date

2026-09

Last Updated

2026-04-08

Healthy Volunteers

No

Interventions

DRUG

Florbetaben 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).

Locations (2)

Royal Free Hospital

London, United Kingdom

King's College London

London, United Kingdom