A multi-center phase 3 study of 18F-florbetaben positron emission tomography/computed tomography (PET-CT) to non-invasively diagnose cardiac AL amyloidosis: the PETAL study.

Conditions

cardiac amyloidosis

Brief summary

Concordance (with 95% confidence interval) of two pathways for diagnosing AL-CA in patients with a monoclonal component: the traditional (invasive) pathway and a noninvasive pathway using 18F-florbetaben PET/CT (visual evaluation).

Detailed description

Sensitivity, specificity, positive and negative predictive value of PET/CT with 18Fflorbetaben (visual evaluation) to diagnose AL-CA compared with the current diagnostic standard., Cut-off di esclusione o di conferma diagnostica di AC tipo AL dalla PET/TC con 18Fflorbetaben (analisi quantitativa) tra i pazienti con sospetto di AC e componente monoclonale;, Variation in the intensity of myocardial uptake of 18F-florbetaben over 12 months in relation to clinical and instrumental variables, safety and tolerability of PET/CT with 18Fflorbetaben in patients in patients with a monoclonal component, assessed in terms of adverse events during the imaging procedure and in the days immediately following

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Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGNeuraceq 300 MBq/mL solution for injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Concordance (with 95% confidence interval) of two pathways for diagnosing AL-CA in patients with a monoclonal component: the traditional (invasive) pathway and a noninvasive pathway using 18F-florbetaben PET/CT (visual evaluation).	—

Secondary

Measure	Time frame
Sensitivity, specificity, positive and negative predictive value of PET/CT with 18Fflorbetaben (visual evaluation) to diagnose AL-CA compared with the current diagnostic standard., Cut-off di esclusione o di conferma diagnostica di AC tipo AL dalla PET/TC con 18Fflorbetaben (analisi quantitativa) tra i pazienti con sospetto di AC e componente monoclonale;, Variation in the intensity of myocardial uptake of 18F-florbetaben over 12 months in relation to clinical and instrumental variables, safety and tolerability of PET/CT with 18Fflorbetaben in patients in patients with a monoclonal component, assessed in terms of adverse events during the imaging procedure and in the days immediately following	—

Measure

Time frame

Sensitivity, specificity, positive and negative predictive value of PET/CT with 18Fflorbetaben (visual evaluation) to diagnose AL-CA compared with the current diagnostic standard., Cut-off di esclusione o di conferma diagnostica di AC tipo AL dalla PET/TC con 18Fflorbetaben (analisi quantitativa) tra i pazienti con sospetto di AC e componente monoclonale;, Variation in the intensity of myocardial uptake of 18F-florbetaben over 12 months in relation to clinical and instrumental variables, safety and tolerability of PET/CT with 18Fflorbetaben in patients in patients with a monoclonal component, assessed in terms of adverse events during the imaging procedure and in the days immediately following

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Countries

Italy

Outcome results

None listed