Condition category
Cancer
Date applied
25/04/2007
Date assigned
01/06/2007
Last edited
21/09/2007
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-P 004

Study information

Scientific title

Acronym

Study hypothesis

The primary objective is to assess the feasibility of manganese chloride tetrahydrate (CMC-001©) as a contrast medium in liver Magnetic Resonance Imaging (MRI) scanning in patients with liver metastases in comparison with gadolinium Benzyloxypropionictetraacetate (BOPTA) (MultiHance©) MRI.

Ethics approval

Approval received from the Regional Ethics Board in Stockholm on the 30th March 2005 (ref: 2005/305-31/1).

Study design

The study will be of a single centre, randomised and open cross-over design.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

Colorectal cancer

Intervention

Each patient will have two MRI sessions, one with each product. This means that each patient will be his/her own control. The evaluation of MR images will be performed by two independent observers. The final evaluation will however be made in consensus.

When a suitable patient arrives at the clinic he/she will be informed about the trial both orally and in writing and is offered a to take part in the trial with two different MRI sessions, one with Gadolinium BOPTA and a second MRI with CMC-001© as contrast. After that he/she will sign the informed consent form.

The patients will visit the clinic three times:
1. For screening and eligibility test
2. For MR imaging of the first contrast
3. For MR imaging of the second contrast

After this, they will be called by phone 24 and 48 hours and asked about Adverse Events (AEs).

The order of administration of the two contrast agents is randomised. MRI after CMC-001© is performed three hours after contrast and MRI after MultiHance©, the comparator, is performed two hours after contrast.

Electrocardiogram (ECG), vital signs, blood for laboratory analyses and urine is drawn at screening and after MRI.

Intervention type

Drug

Phase

Not Specified

Drug names

Manganese chloride tetrahydrate (CMC-001©) and gadolinium BOPTA (MultiHance©).

Primary outcome measures

The primary objective is to assess the feasibility of CMC-001© as a contrast medium in liver MRI scanning in patients with liver metastases in comparison with gadolinium BOPTA (MultiHance©) MRI.

Secondary outcome measures

The secondary objectives are to further evaluate the safety and tolerability of CMC-001© in patients:
1. ECG, vital signs, blood for laboratory analyses and urine is drawn at screening and after MRI
2. AEs are asked for during the whole trial as well as at the phone calls 24 and 48 hours after contrast

Overall trial start date

01/04/2005

Overall trial end date

30/06/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Signed written informed consent after oral and written information about the study has been given by the investigator
2. Patients with one to six liver metastases from colorectal cancer verified with other methods
3. Men or women over 18 years old
4. The patient is conscious and co-operative

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Clinically relevant 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 Electrocardiogram (ECG), haematology, clinical chemistry, serology and urine chemistry abnormalities. This is based on the judgement of the treatment physicians
3. Allergy to any of the study product compounds
4. Drug or alcohol abuse by asking the patient at screening
5. Patients who are deemed to be unsuitable for any other reason in the opinion of the investigator
6. Participation in another clinical study concerning another contrast preparation within the last three months or seven days after this study
7. Previous inclusion in this study
8. Pregnancy after randomisation at the day of MRI before contrast
9. The patient is scheduled to receive intravascular iodinated contrast medium within 24 hours after this study
10. The patient is being investigated on an emergency basis
11. The patient has newly discovered unstable diabetes or undergoes haemodialysis or peritoneal dialysis
12. The patient has a known or suspected clinically severe concurrent illness that may influence the renal function or has undergone kidney, liver or bone marrow transplantation
13. The patient has a concurrent severe illness in the Gastrointestinal (GI) tract like paralysis or malabsorption or clinically manifest icterus
14. Known Human Immunodeficiency Virus (HIV) infection or Acquired Immune Deficiency Syndrome (AIDS)
15. Known hepatitis
16. Known cirrhosis
17. The patient has uncompensated cardiac failure (cardiac failure New York Heart Association [NYHA] grade IV)
18. A patient may be excluded during the trial based on the clinical judgement of the clinician or the radiologist

Recruitment start date

01/04/2005

Recruitment end date

30/06/2007

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-11475
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