title: Phase II clinical trial of gadoteridol injection, a low-osmolal magnetic resonance imaging contrast agent.
abstract: OBJECTIVE
  The safety and efficacy of a new, low-osmolal magnetic resonance imaging contrast medium, gadoteridol injection, were evaluated in a phase II, open-label study at doses ranging from 0.05 to 0.30 mmol/kg.
  
  
  METHODS
  Eighty-six patients with a diagnosis of intracranial tumor received gadoteridol injection followed by magnetic resonance imaging.
  
  
  RESULTS
  Two adverse events (headache, taste disturbance) in 2 of 86 (2.3%) patients were reported. Both were of mild intensity and resolved without treatment and without residual effects. In 4 of 86 (4.7%) patients, 5 laboratory changes were reported by the investigators as possibly related to gadoteridol injection. Efficacy evaluation was conducted in 80 of the 86 patients who received gadoteridol injection. In these patients, a total of 119 lesions was identified, and each was evaluated at four time points after contrast administration, yielding a total of 476 lesion studies. Marked enhancement was demonstrated in 402 of 476 (84%) lesions, whereas slight enhancement was demonstrated in 62 of 476 (13%) lesions. The difference in both the incidence and degree of enhancement of pathology between the predose and postdose images was highly significant (P less than .001).
  
  
  CONCLUSIONS
  Overall, enhanced images provided more diagnostic information and facilitated detection of more lesions than precontrast images. Gadoteridol injection at doses up to 0.3 mmol/kg is a safe and effective magnetic resonance imaging contrast agent for use in patients with intracranial tumors.
authors.affiliation: Squibb Diagnostics, Princeton, NJ 08543.
authors.forename: M J
authors.initials: MJ
authors.lastname: Carvlin
authors.forename: D N
authors.initials: DN
authors.lastname: De Simone
authors.forename: M J
authors.initials: MJ
authors.lastname: Meeks
mesh_terms: D000328:Adult; D000368:Aged; D001921:Brain / Q000473:pathology; D001932:Brain Neoplasms / Q000175:diagnosis; D003287:Contrast Media / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004341:Drug Evaluation; D004361:Drug Tolerance; D005682:Gadolinium / Q000008:administration & dosage*; D006571:Heterocyclic Compounds / Q000008:administration & dosage*; D006801:Humans; D008279:Magnetic Resonance Imaging; D008875:Middle Aged; D009942:Organometallic Compounds / Q000008:administration & dosage*; D013997:Time Factors
chemical_list: D003287:Contrast Media; D006571:Heterocyclic Compounds; D009942:Organometallic Compounds; C062402:gadoteridol; D005682:Gadolinium