title: Manganese chloride tetrahydrate (CMC-001) enhanced liver MRI: evaluation of efficacy and safety in healthy volunteers.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  Liver MRI using 0.8 g CMC-001 has the highest efficacy and still acceptable ADRs and should therefore be preferred.
authors.affiliation: 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
authors.forename: Nils
authors.initials: N
authors.lastname: Albiin
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Kartalis
authors.forename: Annika
authors.initials: A
authors.lastname: Bergquist
authors.forename: Bita
authors.initials: B
authors.lastname: Sadigh
authors.forename: Torkel B
authors.initials: TB
authors.lastname: Brismar
mesh_terms: D000293:Adolescent; D000328:Adult; D003287:Contrast Media / Q000494:pharmacology; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D021621:Imaging, Three-Dimensional / Q000379:methods; D008099:Liver / Q000473:pathology*; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008297:Male; D008345:Manganese / Q000737:chemistry / Q000494:pharmacology*; D008875:Middle Aged; D009132:Muscles / Q000473:pathology; D012449:Safety
chemical_list: C504368:CMC-001; D003287:Contrast Media; D008345:Manganese