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.
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 or with a putative diagnosis of cardiac amyloidosis but with remaining diagnostic uncertainty (e.g., unclear etiology or cardiac manifestation) or patients with diagnosis of amyloidosis but unclear cardiac involvement. The diagnostic efficacy of the visual and quantitative assessments of \[18F\]florbetaben PET images for diagnosis of cardiac AL Amyloidosis will be determined by comparison to the standard of truth (SoT) obtained through standard of care clinical diagnosis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
200
All enrolled patients will undergo \[18F\]florbetaben PET imaging.
St Luke's Hospital
Kansas City, Kansas, United States
RECRUITINGUniversity of Pennsylvania
Philadelphia, Pennsylvania, United States
Sensitivity and specificity of the visual assessment of [18F]florbetaben PET images for the diagnosis of cardiac AL amyloidosis.
The results from the visual assessment of \[18F\]florbetaben PET images are compared to the clinical diagnosis established through histological verification of the presence or absence of AL amyloidosis with cardiac involvement determined either through endomyocardial biopsy or through extracardiac biopsy in conjunction with typical CMR or echocardiography imaging features as the standard of truth.
Time frame: Up to 12 weeks
Sensitivity and specificity of [18F]florbetaben PET for the diagnosis of cardiac AL amyloidosis using quantification.
The sensitivity and specificity of \[18F\]florbetaben PET for the diagnosis of cardiac AL amyloidosis will be determined by using quantitative image analysis.
Time frame: Up to 12 weeks
Correlation of quantitative [18F]florbetaben PET results with left ventricular ejection fraction (LV EF) and left ventricular mass (LV mass).
Correlation of quantitative \[18F\]florbetaben PET results with left ventricular ejection fraction (LV EF) and left ventricular mass (LV mass).
Time frame: Up to 12 weeks
Correlation of quantitative [18F]florbetaben PET results with AL CA stage I - IV based on FLC-diff, cTnT and NT-proBNP levels.
Correlation of quantitative \[18F\]florbetaben PET results with AL CA stage I - IV based on FLC-diff, cTnT and NT-proBNP levels.
Time frame: Up to 12 weeks
Impact of PET imaging (AL-CA/non AL-CA) on diagnostic thinking and patient management will be assessed with physician's questionnaires before and after the diagnostic work-up, and after receipt of the PET results.
The impact of PET imaging (AL-CA/non AL-CA) on diagnostic thinking and patient management will be assessed with physician's questionnaires before and after the diagnostic work-up, and after receipt of the PET results.
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University of Pittsburgh
Pittsburgh, Pennsylvania, United States
RECRUITINGUniversity of Augsburg
Augsburg, Germany
RECRUITINGCharite Berlin
Berlin, Germany
RECRUITINGUniversity of Essen
Essen, Germany
RECRUITINGHOPA Hamburg
Hamburg, Germany
RECRUITINGUniversity of Heidelberg
Heidelberg, Germany
RECRUITINGUniversity of Würzburg
Würzburg, Germany
RECRUITINGHospital University Bellvitge
Barcelona, Spain
RECRUITING...and 4 more locations
Time frame: Up to 14 weeks
Number of adverse events
Safety will be evaluated by collection of Adverse Events.
Time frame: Up to 17 days after imaging visit