Nils Albiin1, Nikolaos Kartalis, Annika Bergquist, Bita Sadigh, Torkel B Brismar. 1. Department of Clinical Science, Intervention and Technology (CLINTEC), Division of Medical Imaging and Technology, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden. nils.albiin@ki.se
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.
RCT Entities:
OBJECT: To evaluate the efficacy of three dose levels of the oral hepatobiliarymanganese-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.
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Authors: Pier Paolo Mainenti; Marcello Mancini; Ciro Mainolfi; Luigi Camera; Simone Maurea; Antonietta Manchia; Michela Tanga; Francesco Persico; Pietro Addeo; Dario D'Antonio; Antonio Speranza; Luigi Bucci; Giovanni Persico; Leonardo Pace; Marco Salvatore Journal: Abdom Imaging Date: 2009-06-27