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
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