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
| ISRCTN | ISRCTN08269491 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08269491 |
| Secondary identifying numbers | CMC-P005 |
- Submission date
- 30/04/2007
- Registration date
- 01/06/2007
- Last edited
- 19/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Lars Vedin
Scientific
Scientific
Lars Vedin AB
Floragatan 13
Stockholm
SE-114 75
Sweden
| Phone | + 46 (0)8 5064 5751 |
|---|---|
| lv@cmc-contrast.se |
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Scientific title | 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 |
| Study objectives | 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(s) | Approval received from the regional ethical committee in Gothenburg on the 7th September 2006 (ref: 235-06). |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/05/2006 |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 16 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2006 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Lars Vedin AB
Stockholm
SE-114 75
Sweden
SE-114 75
Sweden
Sponsor information
Copenhagen Malmö Contrast AB (CMC Contrast AB) (Sweden)
Industry
Industry
c/o Lars Vedin AB
Floragatan 13
Stockholm
SE-114 75
Sweden
| Phone | + 46 (0)8 5064 5751 |
|---|---|
| lv@cmc-contrast.se | |
| Website | http://www.cmc-contrast.se |
"ROR" |
https://ror.org/015x46y72 |
Funders
Funder type
Industry
Copenhagen Malmö Contrast AB (CMC Contrast AB) (Sweden)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
19/10/2021: Proactive update review. No publications found. Search options exhausted.
