EUCTR2005-001254-25-DE进行中（未招募）不适用
Evaluation of the diagnostic efficacy of CMC-001 (manganese chloride tetrahydrate) in liver MR-imaging in patients with liver metastases. A randomised, parallel group, open-label Phase II trial.
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
- •The subject may be included in the study if all of the following criteria are fulfilled at the screening visit:
- •1. Men or women over 18 years old.
- •2. Patients with not more than 10 liver metastases verified with a biphasic multiscan (=16) spiral slice CT less than 2 weeks prior to the screening visit. At least 2 days should elapse between the CT scan and the study start to allow the CT-scan contrast product to disappear.
- •3. Signed written informed consent after oral and written information about the study has been given by the investigator.
- •4. 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
- •If one or more of the following criteria are fulfilled, the subject will not be included in the study:
- •1. Clinically relevant medical history or abnormal physical findings which could interfere with the safety or objectives of the study as judged by the investigator.
- •2. Clinically relevant haematology, clinical chemistry, serology and urine chemistry abnormalities. This is based on the judgement of the treating physicians.
- •3. Concomitant diseases which can interfere with gastrointestinal absorption e.g. malabsorption, gastrectomi or other major surgical interventions in the GI tract.
- •4. Allergy to any of the study product compounds.
- •5. Drug or alcohol abuse by asking the patient at screening.
- •6. Participation in another clinical study concerning another contrast preparation within the last 4 weeks or scheduled 7 days subsequent to this study.
- •7. Previous inclusion in this study.
- •8. Pregnancy (checked at Visit 2 by dip-stick).
- •9. The patient is scheduled to receive contrast medium intravascular within 3 days after this study.
- •10. Any other contrast product within 2 days before the study start.
- •11. The patient is being investigated on an emergency basis.
- •12. The patient has newly discovered unstable diabetes or undergoes haemodialysis or peritoneal dialysis.
- •13. The patient has a concurrent illness that may influence the renal function or has undergone kidney transplantation.
- •14. The patient has a clinically relevant concurrent illness in the GI tract or clinically manifest icterus.
- •15. Known HIV infection or AIDS.
- •16. Hepatitis.
- •17. Liver cirrhosis.
- •18. The patient has uncompensated cardiac failure (cardiac failure NYHA IV).
- •19. Patients who are deemed to be unsuitable for any other reason in the opinion of the Investigator.
- •A patient may be excluded during the trial based on the clinical judgement of the clinician or the radiologist.
研究者
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