title: Effects of gadolinium-based contrast agent concentrations (0.5 M or 1.0 M) on the diagnostic performance of magnetic resonance imaging examinations: systematic review of the literature.
abstract: Background To date there is no agreement as to what is the optimal concentration for gadolinium-based contrast agents (GBCAs). Purpose To assess whether diagnostic performance differences exist between 0.5 M and 1.0 M GBCAs used for magnetic resonance imaging (MRI). Material and Methods A PubMed literature search identified 21 clinical studies published between 2005 and 2013 which evaluated the diagnostic efficacy of both types of GBCAs. Study design, type of procedure, GBCA administration mode, imaging performances, impact on patient management, study limitations, and biases were analyzed. No statistical test was performed on pooled data. Results Sixteen comparative and five non-comparative studies were analyzed, involving 2183 patients who underwent MRI procedures for various indications. In 67% of the studies, 0.5 M and 1.0 M GBCAs were injected at equimolar gadolinium amounts per kg body weight. Only 33% applied the same molar flow rate for delivery of the GBCAs. No significant differences between GBCAs were reported for 23 out of 27 qualitative endpoints (mainly image quality, lesion, and vessel visualization) and 29 out of 40 quantitative endpoints. Three out of four studies with non-equimolar delivery rates showed better contrast-to-noise and signal-to-noise ratios for 1.0 M gadobutrol, without showing an impact on diagnostic performance. Methodological biases were identified in several studies impairing the interpretation of comparisons. Conclusion Imaging differences between 0.5 M and 1.0 M GBCAs were essentially observed under non-equimolar delivery rates. However, they did not result into greater diagnostic efficacy when performed under equimolar conditions.
authors.affiliation: 1 GUERBET, Villepinte, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Lancelot
authors.affiliation: 2 GUERBET AG, Zürich, Switzerland.
authors.forename: John
authors.initials: J
authors.lastname: Froehlich
authors.affiliation: 3 GUERBET GmbH, Sulzbach/Taunus, Germany.
authors.forename: Oliver
authors.initials: O
authors.lastname: Heine
authors.affiliation: 1 GUERBET, Villepinte, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Desché
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D003287:Contrast Media / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D005260:Female; D005682:Gadolinium / Q000008:administration & dosage*; D006801:Humans; D007089:Image Enhancement; D007223:Infant; D007231:Infant, Newborn; D007275:Injections, Intravenous; D008279:Magnetic Resonance Imaging / Q000706:statistics & numerical data*; D008297:Male; D008875:Middle Aged; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D055815:Young Adult
chemical_list: D003287:Contrast Media; D005682:Gadolinium
keywords: Magnetic resonance imaging (MRI); comparative studies; contrast agents – intravenous; efficacy studies