Liver metastases. 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.
Conditions
Sponsors
CMC Contrast AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Signed written informed consent after oral and written information about the study has been given by the investigator. - Patients with 1-6 liver metastases from colorectal cancer verified with other methods. - Men or women over 18 years old - 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
Exclusion criteria
Exclusion criteria: - Clinically relevant medical history or abnormal physical findings which could interfere with the safety or objectives of the study as judged by the investigator. - Clinically relevant haematology, clinical chemistry, serology and urine chemistry abnormalities. This is based on the judgement of the treatment physicians. - Allergy to any of the study product compounds. - Drug or alcohol abuse by asking the patient at screening. - Patients who are deemed to be unsuitable for any other reason in the opinion of the Investigator - Participation in another clinical study concerning another contrast preparation within the last 3 months or 7 days after this study - Previous inclusion in this study - Pregnancy after randomisation at the day of MRI before contrast. - The patient is scheduled to receive intravascular iodinated contrast medium within 24 hours after this study - The patient is being investigated on an emergency basis - Livermetastases that have been treated or are under treatment - The patient has newly discovered unstable diabetes or undergoes haemodialysis or peritoneal dialysis - 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 - The patient has a concurrent severe illness in the GI tract like paralysis or malabsorption or clinically manifest icterus - Known HIV infection or AIDS - Known hepatitis - Known cirrhosis - The patient has uncompensated cardiac failure (cardiac failure NYHA IV) - A patient may be excluded during the trial based on the clinical judgement of the clinician or the radiologist - Fertile women of childbearing age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 Objective: The secondary objectives are to further evaluate the safety and tolerability of CMC-001 in patients. ;Primary end point(s): | — |
Countries
Sweden
Outcome results
None listed