Condition category
Cancer
Date applied
23/04/2007
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

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-P002

Study information

Scientific title

Acronym

Study hypothesis

To assess the fasibility of manganese chloride tetrahydrate (CMC-001©) as a contrast medium in liver Magnetic Resonance Imaging (MRI) scanning.

The secondary objectives are to further evaluate the safety and tolerability of CMC-001© in patients.

Ethics approval

Approval received from the official board of the UMC St Radboud of Nijmegen on the 25th May 2004 (ref: SE/AMO 0339).

Study design

The study was open and non-randomised, with each patient being his own control. The evaluation of the MR images was performed by two independent observers.

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

Verified liver metastases

Intervention

CMC-100© is a contrast agent taken by the oral route intended for use in MRI scanning of the liver, gallbladder and surrounding tissues. In this, the first phase II trial, the intention was to find out how well liver metastases could be visualised in contrast to the surrounding healthy liver tissue. To this end a MRI image taken before contrast was compared to a MRI picture taken three hours after contrast by two independent observers. Some of the patients also had a third MRI 24 hours after contrast in order to see if the gallbladder could be visualised. 48 hours after contrast the patients were called on the phone out of safety reasons in order to find out if they had experienced any Adverse Events (AEs).

No interventions besides the MRI and a screen of blood samples for safety analyses and a special blood sample for manganese alalyse were done.

Intervention type

Drug

Phase

Phase II

Drug names

Manganese chloride tetrahydrate (CMC-001©) contrasting agent

Primary outcome measures

The primary endpoint was efficacy. The MR image before contrast was compared to the MR image three hours after contrast and in a small number of patients also a MR image 24 hours after contrast.

Secondary outcome measures

Secondary parameters was the safety of the contrast. AEs were recorded as long as the patients were staying at the clinic and were called 48 hours after contrast and interviewed about any untoward experiences.

Overall trial start date

01/05/2004

Overall trial end date

01/03/2006

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 liver metastases verified with other imaging techniques
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 haematology, clinical chemistry, serology and urine chemistry abnormalities. This is based on the judgement of the treatment physicians
3. Use of any prescribed, over-the-counter or herbal medication one week prior to entering the study, which might interfere with the safety or the objectives of this study
4. Use of all types of products containing manganese, vitamin D or products containing amino acids during the examination day until after the 24-hour examination
5. Allergy to any of the study product compounds
6. Drug or alcohol abuse by asking the patient at screening
7. Patients who are deemed to be unsuitable for any other reason in the opinion of the investigator
8. Participation in another clinical study concerning another contrast preparation within the last three months or seven days after this study
9. Previous inclusion in this study
10. Pregnancy
11. The patient is scheduled to receive iodinated contrast medium intravascular within three days after this study
12. The patient is being investigated on an emergency basis
13. The patient has newly discovered unstable diabetes or undergoes haemodialysis or peritoneal dialysis
14. The patient has a concurrent illness that may influence the renal function or has undergone kidney transplantation
15. The patient has a concurrent illness in the Gastrointestinal (GI) tract or clinically manifest icterus
16. Known Human Immunodeficiency Virus (HIV) infection or Acquired Immune Deficiency Syndrome (AIDS)
17. Hepatitis
18. The patient has uncompensated cardiac failure (cardiac failure New York Heart Association [NYHA] grade four)
19. A patient may be excluded during the trial based on the clinical judgement of the clinician or the radiologist

Recruitment start date

01/05/2004

Recruitment end date

01/03/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Floragatan 13
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