Colorectal cancer Cancer Colorectal cancer
Conditions
Interventions
Each patient will have two MRI sessions, one with each product. This means that each patient will be his/her own control. The evaluation of MR images will be performed by two independent observers. Th
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 one to six liver metastases from colorectal cancer verified with other methods 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 Electrocardiogram (ECG), haematology, clinical chemistry, serology and urine chemistry abnormalities. This is based on the judgement of the treatment physicians 3. Allergy to any of the study product compounds 4. Drug or alcohol abuse by asking the patient at screening 5. Patients who are deemed to be unsuitable for any other reason in the opinion of the investigator 6. Participation in another clinical study concerning another contrast preparation within the last three months or seven days after this study 7. Previous inclusion in this study 8. Pregnancy after randomisation at the day of MRI before contrast 9. The patient is scheduled to receive intravascular iodinated contrast medium within 24 hours after this study 10. The patient is being investigated on an emergency basis 11. The patient has newly discovered unstable diabetes or undergoes haemodialysis or peritoneal dialysis 12. The patient has a known or suspected clinically severe concurrent illness that may influence the renal function or has undergone kidney, liver or bone marrow transplantation 13. The patient has a concurrent severe illness in the Gastrointestinal (GI) tract like paralysis or malabsorption or clinically manifest icterus 14. Known Human Immunodeficiency Virus (HIV) infection or Acquired Immune Deficiency Syndrome (AIDS) 15. Known hepatitis 16. Known cirrhosis 17. The patient has uncompensated cardiac failure (cardiac failure New York Heart Association [NYHA] grade IV) 18. 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 objective is to assess the feasibility of CMC-001© as a contrast medium in liver MRI scanning in patients with liver metastases in comparison with gadolinium BOPTA (MultiHance©) MRI. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are to further evaluate the safety and tolerability of CMC-001© in patients: 1. ECG, vital signs, blood for laboratory analyses and urine is drawn at screening and after MRI 2. AEs are asked for during the whole trial as well as at the phone calls 24 and 48 hours after contrast | — |
Countries
Sweden
Outcome results
None listed