NL-OMON33542撤回4 期
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
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- Bayer
- 入组人数
- 150
研究概览
简要总结
暂无简介。
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.Patients with known or suspected metachronous liver metastases secondary to colorectal cancer who are scheduled for further contrast-enhanced tomographic imaging
- •2.Patients willing to undergo the study procedures
- •3.Patients who are fully informed about the study and have signed the informed consent form
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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