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

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. CONDITION: Liver magnetic resonance imaging in patients with liver metastases ; Cancer ; Liver cancer PRIMARY OUTCOME: 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. SECONDARY OUTCOME: 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 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