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Manganese Chloride Tetrahydrate (CMC-001) Enhanced Liver MRI: Evaluation of Efficacy and Safety in Healthy Volunteers

Nils Albiin, Nikolaos Kartalis, Annika Bergquist, Bita Sadigh, Torkel B Brismar

MAGMA. 2012 Oct;25(5):361-8.

PMID: 22399275

Abstract:

Object:
To evaluate the efficacy of three dose levels of the oral hepatobiliary manganese-based magnetic resonance imaging (MRI) contrast agent CMC-001, and assess its safety profile and patient acceptability.
Materials and methods:
After ethics committee approval, 32 healthy volunteers (males/females: 18/14) were included. Liver MRI was performed before and 3 h after ingestion of 0.8, 0.4, and 0.2 g of CMC-001 on separate occasions. Liver-to-muscle signal intensity (SI) ratio from baseline to post-contrast and image quality was assessed. Adverse drug reactions/adverse events (ADRs/AEs) and clinico-laboratory tests were monitored.
Results:
The increase in liver-to-muscle SI ratio was significantly higher after 0.8 g (0.696) compared to 0.4 g (0.458) and 0.2 g (0.223) (in all pair-wise comparisons, P < 0.0001). The overall image quality was superior after 0.8 g. ADRs/AEs were dose-related and predominantly of mild intensity.
Conclusion:
Liver MRI using 0.8 g CMC-001 has the highest efficacy and still acceptable ADRs and should therefore be preferred.

Chemicals Related in the Paper:

Catalog Number Product Name Structure CAS Number Price
AP13446349-B Manganese(II) chloride tetrahydrate Manganese(II) chloride tetrahydrate 13446-34-9 Price
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