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.
- Conditions
- iver metastases. CMC - 001 is an orally administered contrast medium containing manganese chloride tetrahydrate (MnCl2 tetrahydrate) 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
- EUCTR2005-001254-25-DE
- Lead Sponsor
- CMC Contrast AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to assess the efficacy and the time-response of CMC - 001 in 2 doses as a contrast medium in liver MRI scanning.;Secondary Objective: The secondary objective is to further evaluate the safety and tolerability of CMC - 001 in patients.;Primary end point(s):
- Secondary Outcome Measures
Name Time Method