Efficacy of [18F]Florbetaben PET for Diagnosis of Cardiac AL Amyloidosis

ID studio #: NCT05184088

condizione: Cardiac Amyloidosis, AL Amyloidosis, ATTR Amyloidosis

stato: reclutamento

scopo:

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.

intervento: [18F]florbetaben

risultati: https://clinicaltrials.gov/ct2/show/results/NCT05184088

ultimo aggiornamento: Dicembre 28, 2023

data d'inizio: Gennaio 13, 2023

completamento previsto: Settembre 2024

ultimo aggiornamento: 16 Febbraio 2023

fase di sviluppo: Fase 3

taglia / iscrizione: 200

descrizione dello studio: 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.

risultati primari:

• 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.
• Fino a 12 settimane
  

risultati secondari:

• Sensitivity and specificity of [18F]florbetaben PET for the diagnosis of cardiac AL amyloidosis using quantification.
  Fino a 12 settimane
• Correlation of quantitative [18F]florbetaben PET results with left ventricular ejection fraction (LV EF) and left ventricular mass (LV mass).
  Fino a 12 settimane
• Correlation of quantitative [18F]florbetaben PET results with AL CA stage I - IV based on FLC-diff, cTnT and NT-proBNP levels.
  Fino a 12 settimane
• 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.
  Fino a 14 settimane
• Number of adverse events
  Up to 17 days after imaging visit

criterio di inclusione:

Criterio di inclusione:

Males and females age ≥18 years
Able to understand, sign and date written informed consent
Written informed consent must be obtained before any assessment is performed
Subjects being considered for a possible diagnosis of cardiac amyloidosis by

1. One of the following conditions:

Established systemic amyloidosis without proven cardiac involvement,
Known plasma cell dyscrasia (MGUS, multiple myeloma),
Pathological free light chain levels in urine or serum,
Presence of heart failure with preserved ejection fraction

2. AND one of the following parameters, indicative of cardiac manifestation:

Mean (left ventricular (LV) wall + septum) thickness >12mm as measured by echocardiography in absence of other known cause of left ventricular hypertrophy (LVH),
NT-proBNP >335 ng/L
Planned diagnostic procedure to establish diagnosis and cardiac involvement (e.g., endomyocardial biopsy or extracardiac biopsy in conjunction with cardiac magnetic resonance imaging/echocardiography or bone scintigraphy)
Female subjects must be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or post-menopausal for at least 1 year (no menses for 12 months without an alternative medical cause). If they are of child-bearing potential, they must commit to use of a highly effective contraceptive measure for at least one week following the PET scan
Male subjects and their partners of childbearing potential must commit to the use of a highly effective method of contraception for a minimum of 90 days following the PET scan
Male subjects must commit to not donate sperm for a minimum of 90 days after the PET scan

criteri di esclusione: criteri:

Any known allergic reactions or hypersensitivity towards any compound of the study drug
Severe hepatic impairment (AST/ALT >5 x ULN; bilirubin >3 x ULN)
Inability to lay flat for up to 60 min
Pregnant, lactating or breastfeeding
Unwilling and/or unable to cooperate with study procedures
Having been administered a radiopharmaceutical within 10 radioactive half-lives prior to study drug administration in this study

sponsor: Life Molecular Imaging GmbH

contatti: Iris Hardewig, PhD, + 49 (0) 30 461 1246 03, [email protected]

investigatori: Andrew Stephens, MD, PhD,Life Molecular Imaging

sedi dei centri di prova:

• Spagna
  Clinica dell'Università di Navarra