EUCTR2008-000583-16-IT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 extra-cellular 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
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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
- •The following patients are to be included in this study: 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
- •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 with the following conditions are to be excluded from this study: 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 impaired renal function (e.g. acute renal failure) or patients on dialysis. 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
相似试验
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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 studyPatients with history of colorectal cancer and known or suspected metachronous liver metastasis(es) scheduled to undergo contrast-enhanced tomographic imaging (i.e. CE-MRI or CE-CT) of the liverMedDRA version: 9.1Level: LLTClassification code 10052358Term: Colorectal cancer metastaticEUCTR2008-000583-16-DEBayer Schering Pharma AG (BSP)660
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 metastasesmetachronous liver metastasesmetastasis in the liver after colorectal cancer10019815NL-OMON33542Bayer150
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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 studyEUCTR2008-000583-16-ATBayer Schering Pharma AG (BSP)660
进行中（未招募）
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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 studyPatients with history of colorectal cancer and known or suspected metachronous liver metastasis(es) scheduled to undergo contrast-enhanced tomographic imaging (i.e. CE-MRI or CE-CT) of the liverMedDRA version: 9.1Level: LLTClassification code 10052358Term: Colorectal cancer metastaticEUCTR2008-000583-16-SEBayer Schering Pharma AG (BSP)660
进行中（未招募）
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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 studyPatients with history of colorectal cancer and known or suspected metachronous liver metastasis(es) scheduled to undergo contrast-enhanced tomographic imaging (i.e. CE-MRI or CE-CT) of the liverMedDRA version: 9.1 Level: LLT Classification code 10052358 Term: Colorectal cancer metastaticEUCTR2008-000583-16-NLBayer Schering Pharma AG (BSP)