EUCTR2005-004176-21-SE进行中（未招募）不适用
Evaluation of the diagnostic efficacy of CMC-001 (MnCl2 tetrahydrate) in MR cholangiography in patients with suspected liver lesions. A randomised, parallel group, open-label Phase II trial.
CMC Contrast AB c/o Öresund Health Care Management0 个研究点开始时间: 2006年4月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Subjects 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 that are referred for MR imaging of the liver for suspected liver pathologies indicated by ultra-sound or CT meriting further investigation.
- •3. Signed written informed consent.
- •4. The patients are 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. 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 investigator.
- •3. Concomitant diseases which can interfere with gastrointestinal absorption e.g. malabsorption, gastrectomi, IBD or major surgical interventions in the GI tract.
- •4. Patients who has undergone papillotomy.
- •5. Patients who have MR contraindications according to the hospital checklist e.g. pacemaker.
- •6. One or more tumour > 10 cm, or several tumours > 5 cm, as judged by ultrasound or CT.
- •7. Allergy to any of the study product ingredients.
- •8. Drug or alcohol abuse.
- •9. Participation in another clinical study concerning pharmaceuticals.
- •10. Previous inclusion in this study.
- •11. Pregnancy (checked at Visit 2 by pregnancy test when relevant).
- •12. Patients scheduled to receive contrast medium intravascularly within 2 days before inclusion or within 3 days after the CMC-001 administration.
- •13. Patients with newly discovered unstable diabetes or undergoing haemodialysis or peritoneal dialysis.
- •14. Known HIV infection or AIDS.
- •15. Confirmed or suspected acute hepatitis.
- •16. Bilirubin = 40 µmol/l.
- •17. Sepsis
- •18. The patient has a non-compensated 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 investigator or the radiologist.
研究者
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