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
- Conditions
- Verified liver metastasesCancerLiver cancer
- Registration Number
- ISRCTN17525991
- Lead Sponsor
- Copenhagen Malmö Contrast AB (CMC Contrast AB) (Sweden)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.