Parametric Cardiac 18F-flutemetamol PET Imaging in ATTR Cardiomyopathy
- Conditions
- Cardiomyopathies, Primary
- Interventions
- Drug: (18F)Flutemetamol
- Registration Number
- NCT05374564
- Lead Sponsor
- Yale University
- Brief Summary
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.
- Detailed 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 12
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- Age > 18 years
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- 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)
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- Plan for initiation of tafamidis therapy for clinical indications and agree to continue tafamidis during the duration of the study.
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- Stated willingness to comply with all study procedures and availability for the duration of the study
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- Able to understand and sign the informed consent document after the nature of the study has been fully explained.
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- 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.
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- Primary amyloidosis (AL) or secondary amyloidosis (AA).
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- Prior liver or heart transplantation.
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- Active malignancy or non-amyloid disease with an expected survival of less than 1 year
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- Inability to lie flat for 60 minutes in the PET scanner
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- History of prior treatment for ATTR cardiomyopathy and/or amyloid neuropathy, or decline clinical tafamidis treatment.
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- Pregnancy or lactation
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- Known allergic reactions to components of the 18F-flutemetamol and/or polysorbate 80
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- High risk for non-adherence as determined by screening evaluation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 18F-flutemetamol (18F)Flutemetamol All clinical trial subjects will receive 18F-flutemetamol
- Primary Outcome Measures
Name Time Method Determine if treatment with tafamidis reduces 18F-flutemetamol cardiac PET imaging markers 6 months As assessed by dynamic cardiac PET between baseline and 6 months
Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol 6 months 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
- Secondary Outcome Measures
Name Time Method Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response 6 months As determined by global longitudinal strain between baseline and following 6 months of treatment with tafamidis.
Trial Locations
- Locations (1)
Yale University
🇺🇸New Haven, Connecticut, United States