EUCTR2008-000583-16-DE进行中（未招募）不适用
Multi-center, randomized comparison study to eVALUatE outcomes and resource needs of imaging and treatment following Primovist-enhanced MRI of the liver in comparison to extracellular contrast media (ECCM)-enhanced MRI and contrast-enhanced computed tomography (CT) in patients with a history of colorectal cancer and known or suspected metachronous liver metastases - Primovist VALUE study
Bayer Schering Pharma AG (BSP)0 个研究点目标入组 660 人开始时间: 2009年8月6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）
- 发起方
- 入组人数
- 660
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
- All
入选标准
- •1. Patients with known or suspected metachronous liver metastases secondary to
- •colorectal cancer who are scheduled for further contrast-enhanced tomographic
- •2. Patients willing to undergo the study procedures
- •3. Patients who are fully informed about the study and have signed 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
- •1. Patients (men or women) under 18 years of age
- •2. Patients who have previously entered this study
- •3. Patients who have received any contrast material within 24 hours before injection
- •of study drug, or who are scheduled to receive any contrast material within
- •24 hours after injection
- •4. Patients who have received or will receive any investigational drug 48 hours
- •before injection of the study drug or during study participation.
- •5. Women who are pregnant, lactating or who are of childbearing potential and have
- •not had a negative urine pregnancy test at baseline visit(s).
- •6. Patients not eligible to contrast media (CM) injection according to product labeling
- •7. Patients scheduled for liver-specific MRI other than Primovist-enhanced MRI, e.g.
- •Multihance-, Teslascan- or SPIO-enhanced MRI
- •8. Patients who require emergency treatment
- •9. Patients who are clinically unstable and whose clinical course is unpredictable
- •(e.g. due to previous surgery, acute myocardial infarction)
- •10. Patients with any physical or mental status that interferes with the signing of
- •informed consent
- •11. Patients with known anaphylactoid or anaphylactic reaction to any contrast
- •media or hypersensitivity to any allergen including drugs
- •12. Patients with a contraindication for MRI or CT.
- •13. Patients with severe renal impairment (eGFR value of < 30 ml/min/1.73m2).
- •14. Close affiliation with the investigational site; e.g., a relative of the investigator,
- •dependent person (e.g., employee or student of the investigational site)
研究者
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