Verified liver metastases Cancer Liver cancer
Conditions
Interventions
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, the first phase II trial, the intention was to find ou
Sponsors
Copenhagen Malmö Contrast AB (CMC Contrast AB) (Sweden)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent after oral and written information about the study has been given by the investigator 2. Patients with liver metastases verified with other imaging techniques 3. Men or women over 18 years old 4. The patient is conscious and co-operative
Exclusion criteria
Exclusion criteria: 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 treatment physicians 3. Use of any prescribed, over-the-counter or herbal medication one week prior to entering the study, which might interfere with the safety or the objectives of this study 4. Use of all types of products containing manganese, vitamin D or products containing amino acids during the examination day until after the 24-hour examination 5. Allergy to any of the study product compounds 6. Drug or alcohol abuse by asking the patient at screening 7. Patients who are deemed to be unsuitable for any other reason in the opinion of the investigator 8. Participation in another clinical study concerning another contrast preparation within the last three months or seven days after this study 9. Previous inclusion in this study 10. Pregnancy 11. The patient is scheduled to receive iodinated contrast medium intravascular within three days after this study 12. The patient is being investigated on an emergency basis 13. The patient has newly discovered unstable diabetes or undergoes haemodialysis or peritoneal dialysis 14. The patient has a concurrent illness that may influence the renal function or has undergone kidney transplantation 15. The patient has a concurrent illness in the Gastrointestinal (GI) tract or clinically manifest icterus 16. Known Human Immunodeficiency Virus (HIV) infection or Acquired Immune Deficiency Syndrome (AIDS) 17. Hepatitis 18. The patient has uncompensated cardiac failure (cardiac failure New York Heart Association [NYHA] grade four) 19. A patient may be excluded during the trial based on the clinical judgement of the clinician or the radiologist
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint was efficacy. The MR image before contrast was compared to the MR image three hours after contrast and in a small number of patients also a MR image 24 hours after contrast. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters was the safety of the contrast. AEs were recorded as long as the patients were staying at the clinic and were called 48 hours after contrast and interviewed about any untoward experiences. | — |
Countries
Netherlands, Sweden
Outcome results
None listed