title: Hemodynamic safety and efficacy of ferumoxytol as an intravenous contrast agents in pediatric patients and young adults.
abstract: OBJECTIVE
  To evaluate the safety and feasibility of off-label use of ferumoxytol as an intravenous MRI contrast agents in pediatric patients and young adults.
  
  
  METHODS
  With HIPAA compliance and IRB approval, 86 consecutive patients who had undergone 3 T or 1.5 T MRI with ferumoxytol were retrospectively identified. The blood pressure and heart rate of patients before and after ferumoxytol injection were compared. The overall image quality was evaluated independently by two radiologists with a four-point scale. Interobserver agreement was calculated using weighted kappa statistics.
  
  
  RESULTS
  The mean±standard deviation (SD) pre and post-contrast systolic blood pressures (SBP) were 101±18 and 95±20, respectively. There was a statistically significant difference between pre-SBP and post-SBP (P=0.003). The pre-contrast diastolic blood pressure (DBP) and the post-contrast diastolic blood pressure (DBP) were 60±14 and 51±17, respectively. There was a statistically significant difference between pre-DBP and post-DBP (P<0.001). The number of patients with SBP and DBP increase, SBP increase and DBP decrease, SBP decrease and DBP increase, SBP and DBP decrease, SBP increase and DBP unchanged were 14 (16%), 9 (10%), 6 (7%), 56 (65%), 1 (1%), respectively. There was moderate agreement on all individual assessments of image quality (kappa=0.45). Eighty-two of 86 (95.4%) studies were scored 3 or above (at least diagnostic quality) by both readers, with 90% confidence interval of 92-99%.
  
  
  CONCLUSIONS
  Ferumoxytol is effective as an MR contrast agent. In our sample, there was on average a small but clinically insignificant drop in SBP and DBP post-contrast injection. Large, randomized, controlled trials are needed to establish optimal dosing, imaging procedures, and safety monitoring.
authors.affiliation: Department of Radiology, Zhengzhou University People's Hospital (Henan Provincial People's Hospital), Zhengzhou, Henan 450003, China. Electronic address: npg1978@126.com.
authors.forename: Peigang
authors.initials: P
authors.lastname: Ning
authors.affiliation: Department of Radiology, Stanford University, Stanford, CA, USA.
authors.forename: Evan J
authors.initials: EJ
authors.lastname: Zucker
authors.affiliation: Department of Pharmacy, Lucile Packard Children's Hospital Stanford, Palo Alto, CA, USA.
authors.forename: Pamela
authors.initials: P
authors.lastname: Wong
authors.affiliation: Department of Radiology, Stanford University, Stanford, CA, USA.
authors.forename: Shreyas S
authors.initials: SS
authors.lastname: Vasanawala
mesh_terms: D000293:Adolescent; D000328:Adult; D001794:Blood Pressure / Q000187:drug effects*; D002648:Child; D002675:Child, Preschool; D003287:Contrast Media / Q000008:administration & dosage / Q000009:adverse effects; D005240:Feasibility Studies; D005260:Female; D052203:Ferrosoferric Oxide / Q000008:administration & dosage* / Q000009:adverse effects*; D006339:Heart Rate / Q000187:drug effects*; D006801:Humans; D007223:Infant; D007275:Injections, Intravenous / Q000009:adverse effects; D018810:Magnetic Resonance Angiography / Q000009:adverse effects*; D008297:Male; D056687:Off-Label Use; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D055815:Young Adult
chemical_list: D003287:Contrast Media; D052203:Ferrosoferric Oxide
keywords: Blood pool agent; Contrast agent; Ferumoxytol; Magnetic resonance angiography; Magnetic resonance imaging; Ultrasmall superparamagnetic iron oxide nanoparticles