Parametric Cardiac 18F-flutemetamol PET Imaging in ATTR Cardiomyopathy

study id #: NCT05374564

condition: Cardiomyopathies, Primary

status: Recruiting

purpose:

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!

intervention: (18F)Flutemetamol

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

last updated: March 10, 2024

start date: August 16, 2022

estimated completion: September 2024

last updated: August 14, 2023

phase of development: Phase 1

size / enrollment: 12

study description: 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).

primary outcomes:

• 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 months
  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 months
  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 months
  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 months
  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 months
  Determine if treatment with tafamidis reduces 18F-flutemetamol cardiac PET imaging markers
  As assessed by dynamic cardiac PET between baseline and 6 months
• 6 months
  

secondary outcomes:

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

inclusion criteria:

Inclusion Criteria:

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.

exclusion criteria: Criteria:

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.

sponsor: Yale University

contacts: Maxime Oriol, BS, 2037856497, [email protected]

investigators: Edward J Miller, MD,Yale University

trial center locations:

• United States, Connecticut
  Yale University
  Edward Miller