Parametric Cardiac 18F-flutemetamol PET Imaging in ATTR Cardiomyopathy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Determine if treatment with tafamidis reduces 18F-flutemetamol cardiac PET imaging markers
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •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)
- •Plan for initiation of tafamidis therapy for clinical indications and agree to continue tafamidis during the duration of the study.
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Able to understand and sign the informed consent document after the nature of the study has been fully explained.
- •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.
排除标准
- •Primary amyloidosis (AL) or secondary amyloidosis (AA).
- •Prior liver or heart transplantation.
- •Active malignancy or non-amyloid disease with an expected survival of less than 1 year
- •Inability to lie flat for 60 minutes in the PET scanner
- •History of prior treatment for ATTR cardiomyopathy and/or amyloid neuropathy, or decline clinical tafamidis treatment.
- •Pregnancy or lactation
- •Known allergic reactions to components of the 18F-flutemetamol and/or polysorbate 80
- •High risk for non-adherence as determined by screening evaluation.
研究组 & 干预措施
18F-flutemetamol
All clinical trial subjects will receive 18F-flutemetamol
干预措施: (18F)Flutemetamol (Drug)
结局指标
主要结局
Determine if treatment with tafamidis reduces 18F-flutemetamol cardiac PET imaging markers
时间窗: 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
时间窗: 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
次要结局
- Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response(6 months)
研究者
Edward J Miller
MD, PhD, Associate Professor of Medicine
Yale University