EUCTR2005-000677-21-SE进行中（未招募）不适用
Evaluation of the diagnostic quality of CMC-001 (manganese chloride tetrahydrate) in liver MR-imaging in patients with liver metastases in comparison to Gadolinium BOPTA. A randomised cross-over Phase III Trial.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •- Signed written informed consent after oral and written information about the study has been given by the investigator.
- •- Patients with 1-6 liver metastases from colorectal cancer verified with other methods.
- •- Men or women over 18 years old
- •- The patient is conscious and co-operative
- •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
- •- Clinically relevant medical history or abnormal physical findings which could interfere with the safety or objectives of the study as judged by the investigator.
- •- Clinically relevant haematology, clinical chemistry, serology and urine chemistry abnormalities. This is based on the judgement of the treatment physicians.
- •- Allergy to any of the study product compounds.
- •- Drug or alcohol abuse by asking the patient at screening.
- •- Patients who are deemed to be unsuitable for any other reason in the opinion of the Investigator
- •- Participation in another clinical study concerning another contrast preparation within the last 3 months or 7 days after this study
- •- Previous inclusion in this study
- •- Pregnancy after randomisation at the day of MRI before contrast.
- •- The patient is scheduled to receive intravascular iodinated contrast medium within 24 hours after this study
- •- The patient is being investigated on an emergency basis
- •- Livermetastases that have been treated or are under treatment
- •- The patient has newly discovered unstable diabetes or undergoes haemodialysis or peritoneal dialysis
- •- The patient has a known or suspected clinically severe concurrent illness that may influence the renal function or has undergone kidney, liver or bone marrow transplantation
- •- The patient has a concurrent severe illness in the GI tract like paralysis or malabsorption or clinically manifest icterus
- •- Known HIV infection or AIDS
- •- Known hepatitis
- •- Known cirrhosis
- •- The patient has uncompensated cardiac failure (cardiac failure NYHA IV)
- •- A patient may be excluded during the trial based on the clinical judgement of the clinician or the radiologist
- •- Fertile women of childbearing age
研究者
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