EUCTR2009-013432-20-DE进行中（未招募）1 期
Intra-individual, randomized comparison of the MRI contrast agents gadobutrol versus gadoterate meglumine in breast MR imaging - Gadovist in breast MRI
Charité Campus Mitte0 个研究点目标入组 52 人开始时间: 2009年6月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 52
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
- •Age: 18-70 years
- •histologically proven breast tumor or suspected benign and malignant lesions, biopsy performed or planned
- •willing to undergo all study procedures
- •having personally signed and dated the informed consent form
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients who are in (or are suspected of) pregnancy or nursery. In women of child bearing potential a pregnancy test must be performed before inclusion in this study
- •Patients with any physical or mental status that interferes with the signing of informed consent
- •any contraindication for MRI
- •having received any contrast material within 12 hours prior to injection with study or comparator drug.
- •requiring emergency treatment
- •Patients with impaired renal function of CKD stadium 3 and higher (e.g. creatinine clearance < 60ml/ min). In patients with known renal impairment, clearance will be calculated based on serum creatinine level using the Cockroft-Gault or MDRD formula. Calculation of the clearance must be done before begin of study.
- •Patients who are scheduled for breast surgery or who would have a biopsy prior to the second planned injection of contrast medium
- •History of anaphylactoid or anaphylactic reaction to any contrast media
- •Having been previously enrolled in this study
研究者
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