NL-OMON43763已完成3 期
on-invasive nodal staging in breast cancer with MRI Lymphography using gadofosveset. - Gadofosveset in breastlesions
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 97 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 97
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Female patient with histopathologically confirmed breast cancer about to undergo nodal staging.
- •2. Willing and able to undergo all study procedures
- •3. Has personally provided written informed consent;Additional inclusion criteria for 2nd axilla-MRI
- •1. Patient treated with neo-adjuvant therapy
- •2. Indication for ALND after neo-adjuvant therapy as result of regular treatment
排除标准
- •1. Age <18
- •2. Pregnancy
- •3. Contra indications for MRI such as pacemaker, aneurysm clips or severe claustrophobia.
- •4. Allergy to any of the ingredients of Gadofosveset (Ablavar®)
- •5. Being unable to give informed consent in person
- •6. Acute or chronic severe renal insufficiency (glomerular filtration rate < 45mL/min/1.73m2)
- •7. Acute renal insufficiency of any severity due to the hepato-renal syndrome
- •8. Known (or suspicion of) QT- prolongation
研究者
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