跳至主要内容
临床试验/NCT01729169
NCT01729169已完成不适用

Diagnosing Cardiac Sarcoidosis Using FDG PET: Optimization

Lars Christian Gormsen1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2012年6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
19
试验地点
1
主要终点
Cardiac sarcoidosis - Sensitivity

研究概览

简要总结

Diagnosing cardiac sarcoidosis has always been challenging: No single imaging modality has proved effective and cardiac biopsies have a very low sensitivity. 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) PET preceded by at least 12 hours of fasting has previously been demonstrated to have reasonable accuracy, however, in some patients physiological FDG uptake in the cardiac region hampers correct identification of sarcoid granulomas. Gallium Ga 68-DOTANOC is a conjugate of the somatostatin analogue Nal3-octreotide (NOC) and gallium Ga 68-labeled 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetic acid (DOTA). We aim to study whether 68Ga-DOTANOC has superior sensitivity and accuracy than 18-FDG PET in diagnosing cardiac sarcoidosis. In addition, we aim to compare 18-FDG PET preceded by 12 hours fasting with 18-FDG PET during somatostatin blockade of insulin mediated cardiac glucose uptake.

详细描述

Intervention:

  • Study A: Subjects with biopsy proven sarcoidosis suspected of cardiac involvement (prone to arrhythmias, cardiac failure, unexplained dyspnea) are studied twice: 1) 18-FDG PET preceded by 12 hours fasting and 2) 18-FDG PET performed during a 2 hour somatostatin blockade (300 microgram/hour)/Heparin infusion.
  • Study B: Subjects with biopsy proven sarcoidosis suspected of cardiac involvement are studied twice: 1) 18-FDG PET preceded by 12 hours fasting and 2) 68Ga-DOTANOC PET preceded by at least 6 hours fasting.

研究设计

研究类型
Observational
观察模型
Case Crossover
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

入选标准

  • Biopsy proven sarcoidosis
  • Suspected cardiac sarcoidosis

排除标准

  • Ischemic heart disease
  • Cardiomyopathy

结局指标

主要结局

Cardiac sarcoidosis - Sensitivity

时间窗: 01/01/2015

Ability to correctly identify patients with cardiac sarcoidosis

次要结局

  • Myocardial cardiac glucose uptake assessed by Cardiac SUV(01/01/2015)

研究者

发起方
Lars Christian Gormsen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lars Christian Gormsen

Consultant, MD PhD

Aarhus University Hospital

研究点 (1)

Loading locations...

相似试验