The Potential Role of 18F-NaF PET/CT in Diagnosing Cardiac Amyloidosis
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Evaluating cardiac amyloidosis imaging efficiency using 18F-NaF PET / CT and quantifying the extent of absorption in SUV standard uptake value
研究概览
简要总结
Cardiac amyloidosis is a common cause of refractory cardiomyopathy and heart failure in an adult population. There are several types of cardiac amyloidosis, but two are the most common (1):
A. AL - Light chain sunset.
B. ATTR - Sunset of transthyretin protein. This amyloidosis has two subtypes:
- Hereditary / familial - due to genetic mutation
- Senile / Wild-type (WT) - Acquired with age
The main goal of this study is to evaluate cardiac amyloidosis imaging efficiency using 18F-NaF PET / CT and quantification of absorption [in standard uptake value SUVs]. and to compare cardiac amyloidosis imaging using 18F-NaF PET / CT and gamma camera imaging with 99mTc-PYP.
详细描述
PET imaging has advantages over gamma imaging, including better resolution, faster and easier testing, and the ability to quantify the absorption intensity. These PET capabilities, potentially, detect subtle differences in disease burden between different heart segments and, subsequently, track response to treatment.
Research Duration:
The entire duration of the study will take about one year (or until all participants in the study complete the tests), As part of the study, tests will be conducted for 20 subjects.
Program details and research steps:
- The study is a prospective study.
- The research was done in collaboration with Prof. Eyal Masheni, Director of the Cyclotron and Radiochemistry Unit at Hadassah Hospital, which will provide twenty doses of 18F-NaF.
- For the Cyclotron and Radiochemistry Unit in Hadassah Hospital, a license to operate as a radiopharmaceutical pharmacy on behalf of the Ministry of Health, and thus valid, a blanket approval by the Ministry of Health to use the materials manufactured therein.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A. Patients undergoing "cardiac amyloidosis clinic" at Tel Aviv Medical Center and there is a clinical suspicion of having cardiac amyloidosis.
- •B. Patients who performed 99mTc-PYP mapping and signed an informed consent form to perform another imaging test, namely, 18F-NaF PET / CT.
排除标准
- 未提供
研究组 & 干预措施
Cardiac amyloidosis patients
干预措施: F18-NaF PET/CT (Diagnostic Test)
结局指标
主要结局
Evaluating cardiac amyloidosis imaging efficiency using 18F-NaF PET / CT and quantifying the extent of absorption in SUV standard uptake value
时间窗: 1 year
次要结局
未报告次要终点