Optimizing Acquisition Parameters and Interpretive Methods of FDG-PET/CT With Rb-82 Myocardial Perfusion Imaging for Evaluation of Cardiac Sarcoidosis
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Visual interpretation of FDG uptake
研究概览
简要总结
In this this investigation, 15 subjects with a high probability of cardiac sarcoidosis based on clinical criteria and abnormal cardiac FDG uptake on initial, clinically indicted FDG PET study will be considered for this study. The study will test the following Aims:
Aim 1. Effect of FDG incubation time on visual and quantitative interpretation of FDG uptake.
Changes in incubation time can affect imaging target:background ratios and study sensitivity/specificity. For the study-directed exam, all patients will undergo sequential cardiacfocused FDG-PET imaging at 90 and 120 minutes after injection of FDG. Imaging variables will be evaluated as below.
Aim 2. Reproducibility of FDG and Rb82 PET findings on sequential imaging. It is unknown whether FDG-positive imaging findings in cardiac sarcoidosis are reproducible. All patients will undergo study-directed FDG-PET/CT with MPI imaging within approximately 2 weeks from initial clinical scan.
详细描述
Sarcoidosis is a systemic disease of unknown etiology characterized by non-caseating granulomatous inflammation. The pathophysiologic features of cardiac sarcoidosis include macrophage-induced, T-cell mediated non-caseating granulomatous inflammation, followed by myocardial scarring/fibrosis with clinical sequelae including arrhythmias, conduction abnormalities, and contractile dysfunction. These lead to high event rates in patients with cardiac sarcoidosis, with several studies reporting a prevalence of ventricular tachycardia ranging from 23% to 38% and an ~ 20% rate of clinical congestive heart failure.
FDG-PET/CT with Rb82 myocardial perfusion imaging (FDG-PET with MPI) is becoming the gold standard imaging technique for evaluating the degree of inflammation and the response to immunosuppressive treatment in patients with cardiac sarcoidosis. FDG PET imaging allows for evaluation of inflammatory macrophage infiltration, while Rb82 MPI allows for determination of myocardial scar burden. Despite emerging data from our center and others on the clinical utility of this technique in predicting prognosis, there is little consensus on the reproducibility of this technique or optimal imaging acquisition techniques and interpretative strategies.
In this study, patients with a high clinical likelihood of cardiac sarcoidosis will undergo a study-directed FDG PET/CT with Rb82 myocardial perfusion imaging study approximately 2 weeks following an initial clinically-directed examination.
The two FDG PET with MPI examinations will be examined for reproducibility of imaging findings, including: SUVmax, SUVmean, distribution of FDG uptake, extra cardiac FDG uptake, SUVvolume, SUVvolume:intensity, perfusion defect size/severity/location, LV ejection fraction, myocardial blood flow.
Strict attention will be paid to ensure patients undergo the same metabolic preparation prior to the two examinations.
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
盲法说明
images will be interpreted without identification
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
- •Palpitations/presyncope/syncope
- •Heart failure symptoms Signs
- •Abnormal ECG or Holter
- •RBBB, LBBB, LAFB
- •Abnormal Q waves in ≥2 leads
- •1st degree AVB > 240 msec, 2nd/3rd deg. AVB
- •Frequent PVCs
- •VT (sustained/non-sustained)
- •LVEF < 50%
- •Cardiac Regional Wall Motion Abnormality
排除标准
- •Low likelihood of CS/Other explanation for symptoms
- •Inability to consent
- •Pregnancy
研究组 & 干预措施
All Participants
Subjects with high-likelihood of cardiac sarcoidosis.
干预措施: Fluorodeoxyglucose (Drug)
All Participants
Subjects with high-likelihood of cardiac sarcoidosis.
干预措施: Rubidium (Drug)
All Participants
Subjects with high-likelihood of cardiac sarcoidosis.
干预措施: FDG-PET/CT with Rb82 Myocardial Perfusion Imaging (Diagnostic Test)
结局指标
主要结局
Visual interpretation of FDG uptake
时间窗: 120 minutes
Images will be evaluated for focal or focal-on-diffuse FDG uptake of the left ventricle or focal RV uptake. The relationship between the location of inflammation and perfusion defects will be characterized ("perfusion metabolism mismatch").
Severity of myocardial inflammation
时间窗: 120 minutes
the maximum standardized uptake value in the heart (cardiac SUV max; g/ml) will be calculated and used to represent the peak level of inflammation.
The extent of inflammation
时间窗: 120 minutes
the volume (cm\^3) of inflamed myocardium will be calculated using a pre-specified threshold of 2.7 as well as by deriving a unique threshold for each patient by multiplying the background activity x 1.5.
次要结局
- Severity of myocardial inflammation(2 weeks after initial scan)
- The extent of inflammation(2 weeks after initial scan)
- Visual interpretation of FDG uptake(2 weeks after initial scan)