Condition category
Cancer
Date applied
30/04/2007
Date assigned
01/06/2007
Last edited
01/06/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.cmc-contrast.se

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes