Evaluation of the diagnostic efficacy of manganese chloride tetrahydrate in liver magnetic resonance imaging in patients with liver metastases: a randomised, parallel group, open-label phase II trial
- Conditions
- iver magnetic resonance imaging in patients with liver metastasesCancerLiver cancer
- Registration Number
- ISRCTN51173608
- Lead Sponsor
- Copenhagen Malmö Contrast AB (CMC Contrast AB) (Sweden)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
1. Men or women over 18 years old
2. Patients with not more than 10 liver metastases verified with a biphasic multiscan (greater than or equal to 16) spiral slice Computed Tomography (CT) less than two weeks prior to the screening visit. At least two 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
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 Gastrointestinal (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 four weeks or scheduled seven days subsequent to this study
7. Previous inclusion in this study
8. Pregnancy (checked at visit two by dip-stick)
9. The patient is scheduled to receive contrast medium intravascular within three days after this study
10. Any other contrast product within two 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 Human Immunodeficiency Virus (HIV) infection or Acquired Immune Deficiency Syndrome (AIDS)
16. Hepatitis
17. Liver cirrhosis
18. The patient has uncompensated cardiac failure (cardiac failure New York Heart Association [NYHA] grade IV)
19. Patients who are deemed to be unsuitable for any other reason in the opinion of the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> The primary objective is to assess the efficacy and the time-response of CMC-001© in two doses as a contrast medium in liver MRI scanning.<br><br> CMC-100 is a contrast agent taken by the oral route intended for use in MRI scanning of the liver, gallbladder and surrounding tissues. In this phase II trial the intention was to find out how well liver metastases could be visualised in contrast to the surrounding healthy liver tissue one, two, three, four and six hours after contrast in order to find the time response of CMC-001.<br><br> To this end a MRI image taken before contrast was compared to a MRI picture taken at the different time points after contrast by two independent observers. 48 hours after contrast the patients were called on the phone out of safety reasons in order to find out if they had experienced any adverse events.<br>
- Secondary Outcome Measures
Name Time Method <br> The secondary objective is to further evaluate the safety and tolerability of CMC-001© in patients:<br> 1. Vital signs is monitored at screening, before contrast and 1, 2, 3, 4, 6 and 24 hours after contrast<br> 2. Electrocardiogram (ECG) is measured at screening, 6 and 24 hours after contrast<br> 3. Clinical laboratory- and urine analyses are analysed at screening and 24 hours after contrast<br> 4. Blood samples for manganese analysis are drawn before contrast and 3 and 24 hours after contrast<br> 5. AEs are asked for during the whole trial including at 24 and 48 hours<br>