The Utility of FDG-PET and PET/CT in the Evaluation of Patients With Suspected Cholecystitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Sensitivity and Specificity of FDG PET/CT and Tc99mHIDA in the Evaluation of Subjects Suspected of Cholecystitis
研究概览
简要总结
This is a pilot study to investigate the ability of fluorodeoxyglucose-positron emission tomography (FDG-PET) and Positron emission tomography-computed tomography (PET/CT) as a direct method of detecting infection and/or inflammation of the gallbladder.
详细描述
Hepatobiliary iminodiacetic acid (HIDA) scan scintigraphy is a nuclear medicine scan used to evaluate patients suspected of having acute cholecystitis (infection/inflammation of the gallbladder). Because it is an indirect test that looks for obstruction of the cystic duct structure, there are many causes for a false-positive HIDA study. There is a need for a more sensitive and specific test that can accurately assess gallbladder infection and/or inflammation.
The purpose of this study is to determine the effectiveness of fluorodeoxyglucose (FDG) as a direct means of detecting patients with acute cholecystitis. FDG is an imaging agent that has previously been shown to accumulate in areas of infection and/or inflammation. The location and intensity of FDG accumulation in the body can be detected with a camera system called a "positron emission tomography" (PET) camera. In theory, this test should be effective in detecting acute infection and/or inflammation of the gallbladder.
Consenting participants will receive injection of FDG one hour prior to the FDG-PET/CT examination. The participant will then be imaged using a PET/CT machine, which is a special camera system that is capable of performing both a PET and CT scan at the same time. A CT scan is an anatomical imaging test and, for this research study, will mainly be used to localize the area of 18FDG accumulation recorded by the PET scan. The examination will take approximately one hour.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •known or high suspicion of cholecystitis
- •highly likely to undergo cholecystectomy
- •positive HIDA study
- •age >18 years old
- •provide written informed consent
排除标准
- •highly unlikely to proceed to surgery or biopsy
- •received an investigational drug within the past 30 days
- •pregnant or lactating
- •decline to provide written informed consent
研究组 & 干预措施
FDG-PET/CT to determine Cholecystitis
19 patients with suspected acute cholecystitis and a positive HIDA will be included in the study. This is purposely a highly selective population which most likely will have surgical proof of the findings. Subjects will receive an FDG PET/CT exam to determine the presence of gallbladder inflammation/infection(cholecystitis). Please note that 18FDG is an FDA approved radiopharmaceutical.
干预措施: 18FDG (an FDA-approved radiopharmaceutical) (Drug)
结局指标
主要结局
Sensitivity and Specificity of FDG PET/CT and Tc99mHIDA in the Evaluation of Subjects Suspected of Cholecystitis
时间窗: 1-2 days through the post operative period
Percent of patients identified of having cholecystitis using FDG PET/CT compared to patients identified of having pathological diagnosis of cholecystitis (sensitivity) Percent of patients identified of not having cholecystitis using FDG PET/CT compared to patients identified of not having pathological diagnosis of cholecystitis (specificity) * number of false positives = number of patients incorrectly identified of having cholecystitis using FDG PET/CT compared to a negative pathological diagnosis. * number of false negatives = number of patients incorrectly identified of not having cholecystitis using FDG PET/CT compared to a positive pathological diagnosis. * number of true positives = number of patients correctly identified of having cholecystitis using FDG PET/CT compared to a positive pathological diagnosis. * number of true negatives = number of patients correctly identified of not having cholecystitis using FDG PET/CT compared to a negative pathological diagnosis.
次要结局
未报告次要终点
研究者
Alan D. Waxman, M.D.
Director, Imaging / Nuclear Medicine / Nuclear Cardiology
Cedars-Sinai Medical Center