Evaluation of the diagnostic efficacy of manganese chloride tetrahydrate in liver magnetic resonance imaging in patients with liver metastases: a randomised, parallel group, open-label phase II trial

ISRCTN	ISRCTN51173608
DOI	https://doi.org/10.1186/ISRCTN51173608
Protocol serial number	CMC-P003
Sponsor	Copenhagen Malmö Contrast AB (CMC Contrast AB) (Sweden)
Funder	Copenhagen Malmö Contrast AB (CMC Contrast AB) (Sweden)

Submission date: 24/04/2007
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

Floragatan 13
Stockholm
SE-114 75
Sweden

Phone	+46 (0)8 5064 5751
Email	lv@cmc-contrast.se

Study information

Primary study design	Interventional
Study design	This is an open, parallel group, randomised, single dose, single centre study in patients diagnosed with liver metastases.
Secondary study design	Randomised controlled trial
Scientific title	Evaluation of the diagnostic efficacy of manganese chloride tetrahydrate in liver magnetic resonance imaging in patients with liver metastases: a randomised, parallel group, open-label phase II trial
Study objectives	Primary objectives: The primary objective is to assess the efficacy and the time-response of manganese chloride tetrahydrate (CMC-001©) in two doses as a contrast medium in liver Magnetic Resonance Imaging (MRI) scanning. Secondary objectives: The secondary objective is to further evaluate the safety and tolerability of CMC-001© in patients.
Ethics approval(s)	Approval received from the local ethics committee (Ethik-Kommission des Landes Berlin) on the 8th March 2006 (ref: EK 5 302/05).
Health condition(s) or problem(s) studied	Liver magnetic resonance imaging in patients with liver metastases
Intervention	The trial was open meaning that all patients had active drug. There was no comparator. Each patient will visit the clinic on three occasions: 1. The screening visit 2. For dosing and MR imaging 3. For a follow-up In addition, a telephone follow-up is 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 MR imaging pre-dose and 1, 2, 3, and 6 hours post dose. Two different doses were used: Full dose and Half dose. Every patient was randomised to one of these doses. After 24 hours the patients returned to the clinic for a safety follow up and all patients were contacted by telephone after 48 hours when Adverse Events (AEs) were asked for. Patients also provided blood samples for safety blood tests and blood sampling for manganese analysis.
Intervention type	Drug
Phase	Phase II
Drug / device / biological / vaccine name(s)	Manganese chloride tetrahydrate (CMC-001©)
Primary outcome measure(s)	The primary objective is to assess the efficacy and the time-response of CMC-001© in two doses as a contrast medium in liver MRI scanning. 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 phase II trial the intention was to find out how well liver metastases could be visualised in contrast to the surrounding healthy liver tissue one, two, three, four and six hours after contrast in order to find the time response of CMC-001. To this end a MRI image taken before contrast was compared to a MRI picture taken at the different time points after contrast by two independent observers. 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.
Key secondary outcome measure(s)	The secondary objective is to further evaluate the safety and tolerability of CMC-001© in patients: 1. Vital signs is monitored at screening, before contrast and 1, 2, 3, 4, 6 and 24 hours after contrast 2. Electrocardiogram (ECG) is measured at screening, 6 and 24 hours after contrast 3. Clinical laboratory- and urine analyses are analysed at screening and 24 hours after contrast 4. Blood samples for manganese analysis are drawn before contrast and 3 and 24 hours after contrast 5. AEs are asked for during the whole trial including at 24 and 48 hours
Completion date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	20
Key inclusion criteria	1. Men or women over 18 years old 2. Patients with not more than 10 liver metastases verified with a biphasic multiscan (greater than or equal to 16) spiral slice Computed Tomography (CT) less than two weeks prior to the screening visit. At least two days should elapse between the CT-scan and the study start to allow the CT-scan contrast product to disappear 3. Signed written informed consent after oral and written information about the study has been given by the investigator 4. The patient is conscious and co-operative
Key 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 treating physicians 3. Concomitant diseases which can interfere with gastrointestinal absorption e.g. malabsorption, gastrectomi or other major surgical interventions in the Gastrointestinal (GI) tract 4. Allergy to any of the study product compounds 5. Drug or alcohol abuse by asking the patient at screening 6. Participation in another clinical study concerning another contrast preparation within the last four weeks or scheduled seven days subsequent to this study 7. Previous inclusion in this study 8. Pregnancy (checked at visit two by dip-stick) 9. The patient is scheduled to receive contrast medium intravascular within three days after this study 10. Any other contrast product within two days before the study start 11. The patient is being investigated on an emergency basis 12. The patient has newly discovered unstable diabetes or undergoes haemodialysis or peritoneal dialysis 13. The patient has a concurrent illness that may influence the renal function or has undergone kidney transplantation 14. The patient has a clinically relevant concurrent illness in the GI tract or clinically manifest icterus 15. Known Human Immunodeficiency Virus (HIV) infection or Acquired Immune Deficiency Syndrome (AIDS) 16. Hepatitis 17. Liver cirrhosis 18. The patient has uncompensated cardiac failure (cardiac failure New York Heart Association [NYHA] grade IV) 19. Patients who are deemed to be unsuitable for any other reason in the opinion of the investigator
Date of first enrolment	01/08/2005
Date of final enrolment	31/12/2007

Locations

Countries of recruitment

Germany
Sweden

Study participating centre

Floragatan 13

Stockholm
SE-114 75
Sweden

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Editorial Notes

19/10/2021: Proactive update review. No publications found. Search options exhausted.