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临床试验/EUCTR2012-002991-15-NL
EUCTR2012-002991-15-NL进行中(未招募)不适用

MR-imaging to diagnose endometriosis using Ablavar ® as contrast agent – a feasibility study’

未提供0 个研究点开始时间: 2012年10月19日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Female

入选标准

  • 18 years and older;
  • Suspicion of peritoneal endometriosis, palpable nodule located at the sacrouterine ligaments at physical examination;
  • Patient planned for MRI and laparoscopic diagnosis and treatment of the disease (care as usual);
  • Pre menopausal;
  • Using contraception during the time of the study;
  • Willing and able to undergo all study procedures;
  • Written informed consent.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 5
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Pregnancy / breast feeding;
  • Post menopausal or under GnRH analogue treatment;
  • Patients presenting with a contraindication to MRI such as pacemaker, aneurysm clip, severe claustrophobia or ferromagnetic implants;
  • Impaired kidney function or acute kidney injury;
  • History of severe allergic reaction or allergic reaction to MR contrast media;
  • Allergy (hypersensitivity) to any of the ingredients of Ablavar ®;
  • Being unable to give informed consent in person.

研究者

发起方
未提供

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