Imágenes PET paramétricas cardíacas con 18F-flutemetamol en la miocardiopatía ATTR

ID de estudio #: NCT05374564

condición: Cardiomyopathies, Primary

Estado: Reclutamiento

propósito:

18F-Flutemetamol (Vizamyl) is a radioactive diagnostic agent indicated and FDA-approved for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) or other causes of cognitive decline. This study is designed to evaluate a novel use for 18F-Flutemetamol in cardiac amyloidosis!

intervención: (18F)Flutemetamol

Resultados: https://clinicaltrials.gov/ct2/show/results/NCT05374564

última actualización: Marzo 10, 2024

fecha de inicio: 16 de agosto de 2022

finalización estimada: Septiembre 2024

última actualización: 14 de agosto de 2023

fase de desarrollo: Fase 1

tamaño / inscripción: 12

descripción del estudio: The goal of this project is to perform a proof-of-concept study to compare the ability of quantitative parametric cardiac 18F-flutemetamol positron emission tomography (PET) to assess baseline and change in disease burden after six months of therapy with tafamidis treatment in 12 patients diagnosed with transthyretin cardiac amyloidosis (ATTR-CA) at Yale-New Haven Hospital. The primary outcome of the study will be comparisons in the magnitude of change in regional and global 18F-flutemetamol cardiac PET metrics between the baseline and six-month 18F-flutemetamol PET scans versus clinical stage and echocardiographic features (wall thickness, strain, LVEF).

resultados primarios:

• Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol
  As determined by comparisons in the magnitude of change in regional and global 18F-flutemetamol cardiac PET visual uptake scores between the baseline and six-month PET scans
• 6 meses
  Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol
  As determined by comparisons in the magnitude of change in regional and global 18F-flutemetamol cardiac PET percent maximal counts between the baseline and six-month PET scans
• 6 meses
  Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol
  As determined by comparisons in the magnitude of change in regional and global 18F-flutemetamol cardiac PET Standardized Uptake Values (SUVs) between the baseline and six-month PET scans
• 6 meses
  Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol
  As determined by comparisons in the magnitude of change in regional and global 18F-flutemetamol cardiac PET retention index between the baseline and six-month PET scans
• 6 meses
  Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol
  As determined by comparisons in the magnitude of change in regional and global 18F-flutemetamol cardiac PET Vt between the baseline and six-month PET scans
• 6 meses
  Determine if treatment with tafamidis reduces 18F-flutemetamol cardiac PET imaging markers
  As assessed by dynamic cardiac PET between baseline and 6 months
• 6 meses
  

resultados secundarios:

• Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response
  6 meses
• Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response
  6 meses
• Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response
  6 meses
• Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response
  6 meses
• Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response
  6 meses

criterios de inclusión:

Criterios de inclusión:

1. Age > 18 years

2. Diagnosis of ATTR cardiac amyloidosis (wild-type or V142I ATTR mutation)

a. Diagnosis of ATTR cardiac amyloidosis by established consensus diagnostic criteria of Gillmore et al. (either invasive or non-invasive diagnostic pathways)

3. Plan for initiation of tafamidis therapy for clinical indications and agree to continue tafamidis during the duration of the study.
4. Stated willingness to comply with all study procedures and availability for the duration of the study
5. Able to understand and sign the informed consent document after the nature of the study has been fully explained.
6. Women of childbearing potential who are sexually active with a non-sterilized male partner and males who are sexually active with a partner of childbearing potential must agree to use adequate contraception from screening until 30 days after the Flutemetamol.

Criterio de exclusión: Criterios:

1. Primary amyloidosis (AL) or secondary amyloidosis (AA).
2. Prior liver or heart transplantation.
3. Active malignancy or non-amyloid disease with an expected survival of less than 1 year
4. Inability to lie flat for 60 minutes in the PET scanner
5. History of prior treatment for ATTR cardiomyopathy and/or amyloid neuropathy, or decline clinical tafamidis treatment.
6. Pregnancy or lactation
7. Known allergic reactions to components of the 18F-flutemetamol and/or polysorbate 80
8. High risk for non-adherence as determined by screening evaluation.

patrocinador: Universidad de Yale

Contactos: Maxime Oriol, BS, 2037856497, GME@dhr-rgv.com

investigadores Edward J Miller, MD,Yale University

ubicaciones del centro de prueba:

• Estados Unidos, Connecticut
  Universidad de Yale
  eduardo molinero