Evaluation of the diagnostic efficacy of manganese chloride tetrahydrate (CMC-001©) in magnetic resonance cholangiography in patients with suspected liver lesions: a randomised, parallel group, open-label phase II trial

Phase 2

Completed

• Conditions: Magnetic resonance imaging of the liver, bile ducts and the gall bladder.; Cancer; Suspected liver, bile duct and gall bladder lesions

• Registration Number: ISRCTN08269491
• Lead Sponsor: Copenhagen Malmö Contrast AB (CMC Contrast AB) (Sweden)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-01
• Study Completion: 2007-12-31
• Last Update Posted: 1 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

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 Computed Tomgraphy (CT) meriting further investigation
3. Signed written informed consent
4. The patients are conscious and co-operative

Exclusion Criteria

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, based on the judgement of the investigator
3. Concomitant diseases which can interfere with gastrointestinal absorption, e.g., malabsorption, gastrectomy, Irritable Bowel Disease (IBD) or major surgical interventions in the Gastrointestinal (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 greater than 10 cm, or several tumours greater than 5 cm, as judged by ultra-sound 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 two by pregnancy test when relevant)
12. Patients scheduled to receive contrast medium intravascularly within two days before inclusion or within three days after the CMC-001© administration
13. Patients with newly discovered unstable diabetes or undergoing haemodialysis or peritoneal dialysis
14. Known Human Immunodeficiency Virus (HIV) infection or Acquired Immune Deficiency Syndrome (AIDS)
15. Confirmed or suspected acute hepatitis
16. Bilirubin less than 40 µmol/l
17. Sepsis
18. The patient has a non-compensated cardiac failure (cardiac failure New York Heart Association [NYHA] grade four)
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
The primary objective is to assess the efficacy and the time-response of CMC-001© in two dose levels as a contrast medium in MR-cholangiography and to further evaluate the safety and tolerability of CMC-001© in patients.

Secondary Outcome Measures

Name	Time	Method
<br> 1. 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<br> 2. To assess and compare the visualisation and delineation of focal liver lesions before contrast and after 2.5 and 4 hours after administration of CMC-001©<br> 3. To assess the extent to which the pancreatic duct is filled 2.5 and 4 hours post administration of CMC-001©<br>