Non-alcoholic Fatty Liver Disease Parametric PET (FLiPP) Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- PET scan parameters correlated with biopsy findings
研究概览
简要总结
The goal of this study is to evaluate non-invasive imaging techniques for determining liver steatosis (fat), inflammation (abnormal tissue swelling), and fibrosis (abnormal tissue scarring).In addition, the study group will be using other test measures including personal demographics, laboratory blood test results, and imaging measurements to determine the severity of NAFLD (non-alcoholic fatty liver disease), NASH (non-alcoholic steatohepatitis), inflammation, and fibrosis.
详细描述
The study group proposes to evaluate the role of fluorodeoxyglucose (FDG) positron emission tomography (PET) in the determination of steatohepatitis and in combination with MRI for detection, differentiation and quantitation of liver steatosis, steatohepatitis and fibrosis in correlation to liver biopsy. Patient enrolled in this will already have had their liver biopsy or will be undergoing liver biopsy as a part of their clinical care as determined by their provider and will not be getting biopsies solely to be enrolled in the study. Current treatment options for patients that liver biopsy is being performed are limited to lifestyle changes and vitamin E for patients without diabetes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patients >18 years age
- •Patients who had or will have a liver biopsy as standard of care for fatty liver disease and have risk factors for NASH. Liver biopsy needs to be within 6 months of planned imaging.
- •Patients undergoing bariatric surgery and will have a liver biopsy as standard of care.
- •Ability to provide informed consent.
排除标准
- •History of alcohol abuse, chronic hepatitis B or C, or other chronic liver disease other than non-alcoholic fatty liver disease.
- •Pregnant women
- •Claustrophobic to MRI
- •Allergic to FDG dye
- •Patients who are unable to lie in the scanner for one hour
结局指标
主要结局
PET scan parameters correlated with biopsy findings
时间窗: one year
PET scan parameters correlated with biopsy findings (NAFLD Activity Score as per NASH-CRN)
次要结局
未报告次要终点