Contact information
Type
Scientific
Primary contact
Dr Lars Vedin
ORCID ID
Contact details
Lars Vedin AB
Floragatan 13
Stockholm
SE-114 75
Sweden
+ 46 (0)8 5064 5751
lv@cmc-contrast.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CMC-P005
Study information
Scientific title
Acronym
Study hypothesis
The primary objective is to assess the efficacy and the time-response of manganese chloride tetrahydrate (CMC-001©) in two dose levels as a contrast medium in Magnetic Resonance (MR)-cholangiography and to further evaluate the safety and tolerability of CMC-001© in patients.
Ethics approval
Approval received from the regional ethical committee in Gothenburg on the 7th September 2006 (ref: 235-06).
Study design
This study is an open label, parallel group, randomised, single centre study in patients with suspected liver lesions.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Condition
Magnetic resonance imaging of the liver, bile ducts and the gall bladder.
Intervention
Patients with suspected liver lesions will be given either a full dose (1.6 g) or half dose (0.8 g) of CMC-001©. A total of 16 fully evaluable patients will be included, 8 patients in each treatment arm. The study will be conducted at one site in Sweden.
Each patient will visit the clinic on three occasions:
1. The screening visit
2. For Magnetic Resonance Imaging (MRI)
3. For a follow-up
In addition, a telephone follow-up will be performed 48 hours after administration of CMC-001©. The total study duration for each patient is not more than 10 days. The patients are assessed by MRI at pre-dose and 2.5 and 4 hours post dose.
Every patient will have three visits to the clinic at screening when MRI is done and blood samples for laboratory analyses is done, at the treatment day when two MRIs are done at 2.5 hours and 4 hours after contrast. The third occasion is a visit to the clinic 24 hours after contrast for safety reasons with new blood samples for laboratory testing is drawn. All patients will also be contacted by telephone 48 hrs after contrast when Adverse Events (AEs) will be asked for.
Intervention type
Drug
Phase
Phase II
Drug names
Manganese chloride tetrahydrate (CMC-001©)
Primary outcome measure
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
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
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©
3. To assess the extent to which the pancreatic duct is filled 2.5 and 4 hours post administration of CMC-001©
Overall trial start date
01/05/2006
Overall trial end date
31/12/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
16
Participant 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
Recruitment start date
01/05/2006
Recruitment end date
31/12/2007
Locations
Countries of recruitment
Sweden
Trial participating centre
Lars Vedin AB
Stockholm
SE-114 75
Sweden
Sponsor information
Organisation
Copenhagen Malmö Contrast AB (CMC Contrast AB) (Sweden)
Sponsor details
c/o Lars Vedin AB
Floragatan 13
Stockholm
SE-114 75
Sweden
+ 46 (0)8 5064 5751
lv@cmc-contrast.se
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Copenhagen Malmö Contrast AB (CMC Contrast AB) (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list