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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
15
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).
Royal Free Hospital
London, United Kingdom
RECRUITINGKing's College London
London, United Kingdom
COMPLETEDTest-Retest variability of cardiac [18F]florbetaben PET uptake
Percent Test-Retest variability (%) of cardiac 18F florbetaben PET
Time frame: The duration of the study for participants may be up to 73 days.
Test-Retest variability of extracardiac [18F]florbetaben uptake
Percent Test-Retest variability (%) of extracardiac 18F forbetaben PET
Time frame: The duration of the study for participants may be up to 73 days.
Net influx rate derived from full tracer kinetic modelling
Net influx rate Ki \[ml/cm3/min\]
Time frame: The duration of the study for participants may be up to 73 days.
Volume of distribution derived from full tracer kinetic modelling
Volume of distribution Vd
Time frame: The duration of the study for participants may be up to 73 days.
Safety and tolerability of [18F]florbetaben
Number of participants with treatment-related adverse events as assessed by CTCAE version 5.0.
Time frame: The duration of the study for participants may be up to 73 days.
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