跳至主要内容
临床试验/NCT00332943
NCT00332943已完成4 期

MR Colonography With Fecal Tagging. Barium vs. BariumFerumoxsil

Herlev Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2005年12月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
20
试验地点
1
主要终点
Quality of fecal tagging agent

研究概览

简要总结

The purpose of this study is to determine whether Barium or BariumFerumoxsil is better for fecal tagging in MR colonography. Patients referred to colonoscopy are offered MR colonography before colonoscopy. Two days before colonography, patients ingest either a contrast agent A (200 ml Barium sulphate solution 1g/ml)) four times a day or a 200 ml contrast agent B (Barium sulfate(25%) and Ferumoxil(75%)) four times a day, which will render fecal masses "invisible" on the following MR colonography. The patients are randomised to either contrast agent A or B. The examinations are evaluated by two independent blinded readers, who will rate the tagging quality of the contrast agents. The quality of tagging will be rated by a Visual Analog Scale (VAS) and Relative contrast (ReCon = Iwall - Ilumen/ Iwall + Ilumen).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single

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

  • Suspicion of colorectal polyps or cancer
  • Referred for colonoscopy

排除标准

  • Suspicion of IBD
  • Pacemaker
  • Metal in the body
  • Claustrophobia
  • Pregnancy

结局指标

主要结局

Quality of fecal tagging agent

Sensitivity of VAS score vs. ReCon score

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

Loading locations...

相似试验