Liver lesions. 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
Interventions
Product Name: CMC-001
Product Code: CMC-001
Pharmaceutical Form: Powder for oral suspension
INN or Proposed INN: Manganese chloride tetrahydrate
CAS Number: 13446-34-9
Concentration unit: g gram(s)
Co
Sponsors
CMC Contrast AB c/o Öresund Health Care Management
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects 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 that are referred for MR imaging of the liver for suspected liver pathologies indicated by ultra-sound or CT meriting further investigation. 3. Signed written informed consent. 4. The patients are 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: If one or more of the following criteria are fulfilled, the subject will not be included in the study: 1. 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 investigator. 3. Concomitant diseases which can interfere with gastrointestinal absorption e.g. malabsorption, gastrectomi, IBD or major surgical interventions in the GI tract. 4. Patients who has undergone papillotomy. 5. Patients who have MR contraindications according to the hospital checklist e.g. pacemaker. 6. One or more tumour > 10 cm, or several tumours > 5 cm, as judged by ultrasound or CT. 7. Allergy to any of the study product ingredients. 8. Drug or alcohol abuse. 9. Participation in another clinical study concerning pharmaceuticals. 10. Previous inclusion in this study. 11. Pregnancy (checked at Visit 2 by pregnancy test when relevant). 12. Patients scheduled to receive contrast medium intravascularly within 2 days before inclusion or within 3 days after the CMC-001 administration. 13. Patients with newly discovered unstable diabetes or undergoing haemodialysis or peritoneal dialysis. 14. Known HIV infection or AIDS. 15. Confirmed or suspected acute hepatitis. 16. Bilirubin = 40 µmol/l. 17. Sepsis 18. The patient has a non-compensated 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 investigator or the radiologist.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the efficacy and the time-response of CMC-001 in 2 dose levels as a contrast medium in MR-cholangiography and to further evaluate the safety and tolerability of CMC-001 in patients.;Secondary Objective: The secondary objectives are to: - assess if CMC-001-enhanced MR cholangiography provides an equally good or improved image quality of the non-dilated biliary tree in comparison to T2-weighted MR cholangiography. - assess and compare the visualization and delineation of focal liver lesions before contrast and after 2.5 and 4 hours after administration of CMC-001. - assess the extent to which the pancreatic duct is filled 2.5 and 4 hours post administration of CMC-001;Primary end point(s): The following efficacy endpoints will be drived/assessed from the MR images: - Quality of diagnostic information of bile ducts and liver parenchyma. - Delineation of the biliary tract and degree of ductal visualization. - Signal to noise ratio in the extrahepatic bile duct. - Contrast to noise ratio between the extrahepatic bile duct and the liver. - Subjective analysis of pre-dosing and post dosing images regarding visualisation of the biliary tract. - Subjective analysis of the time-response effect measured by comparing ductal visualisation at the 2.5 and 4 hr images. - Subjective analysis of the visualisation and delineation of focal lesions in the liver parenchyma by comparing the 0 hr images with the 2.5 and 4 hr images. - Extent of filling of the pancreatic duct. Each of these endpoints will be evaluated by means of the MRI equipment. The safety endpoints are the number of AEs that are judged to be possibly related to the investigational products. | — |
Countries
Sweden
Outcome results
None listed