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.

• Conditions: iver lesions. CMC-001 is an orally administered contrast medium containing manganese (Mn) as the active imaging substance. Manganese is absorbed by the healthy parts of the liver and will thus create contrast to liver lesions in MRI.

• Registration Number: EUCTR2005-004176-21-SE
• Lead Sponsor: CMC Contrast AB c/o Öresund Health Care Management

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified