Evaluation of the diagnostic quality of manganese chloride tetrahydrate (CMC-100©) in liver magnetic resonance imaging in patients with known liver metastases: a phase II trial

ISRCTN	ISRCTN17525991
DOI	https://doi.org/10.1186/ISRCTN17525991
Secondary identifying numbers	CMC-P002

Submission date: 23/04/2007
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

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
Study setting(s)	Hospital
Study type	Diagnostic
Scientific title	Evaluation of the diagnostic quality of manganese chloride tetrahydrate (CMC-100©) in liver magnetic resonance imaging in patients with known liver metastases: a phase II trial
Study objectives	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(s)	Approval received from the official board of the UMC St Radboud of Nijmegen on the 25th May 2004 (ref: SE/AMO 0339).
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	Manganese chloride tetrahydrate (CMC-001©) contrasting agent
Primary outcome measure	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 study start date	01/05/2004
Completion date	01/03/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	20
Key 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
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 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
Date of first enrolment	01/05/2004
Date of final enrolment	01/03/2006

Locations

Countries of recruitment

Netherlands
Sweden

Study participating centre

Floragatan 13

Stockholm
SE-114 75
Sweden

Sponsor information

Copenhagen Malmö Contrast AB (CMC Contrast AB) (Sweden)
Industry

c/o Lars Vedin AB
Floragatan 13
Stockholm
SE-114 75
Sweden

Phone	+46 (0)8 5064 5751
Email	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.