跳至主要内容
临床试验/NCT01002261
NCT01002261已完成不适用

Determination of Hepatic Metabolism of Galactose and the Galactose Analog FDGal in Patients With Liver Disease and Healthy Subjects

Aarhus University Hospital1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2009年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
16
试验地点
1
主要终点
Lumped constant for recalculation of PET/CT data for FDGalactose to data for natural galactose

研究概览

简要总结

The elimination of the carbohydrate galactose is used in daily clinical work with liver patients as a quantitative measure of metabolic liver function, as the liver test "The Galactose Elimination Capacity", GEC. We are working to develop a PET/CT scanning procedure for providing 3D images of the hepatic galactose elimination and measurement of regional values. This may be used for example for planning resection or stereotactic radiotherapy of a patient with malignant tumor in the liver. Will the patient be able to tolerate removal of the necessary part of the liver? We will include 10 patients with liver cirrhosis and 6 healthy human subjects. Direct measurements of the hepatic galactose elimination (successive constant iv infusions of galactose in increasing doses with measurements of blood concentrations of galactose in blood from an artery and a liver vein, and measurements of liver blood flow by indocyanine green, Ficks principle) are compared with PET/CT measurements after iv injection of a 18F-labelled galactose analog, FDGal.

Based on previous studies in pigs, we perform detailed calculations of the hepatic galactose elimination kinetics by the two methods, including estimation of a factor ("lumped constant") for recalculating PET/CT data to data for natural galactose.

Besides possible practical clinical importance, the project elucidates basic problems concerning liver metabolism using PET.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • liver cirrhosis

排除标准

  • hepatic encephalopathy
  • pregnancy

结局指标

主要结局

Lumped constant for recalculation of PET/CT data for FDGalactose to data for natural galactose

时间窗: May 2011

次要结局

未报告次要终点

研究者

发起方
Aarhus University Hospital
申办方类型
Other

研究点 (1)

Loading locations...

相似试验