Hemodynamic safety and efficacy of ferumoxytol as an intravenous contrast agents in pediatric patients and young adults.

Purpose To evaluate the safety and feasibility of off-label use of ferumoxytol as an intravenous MRI contrast agents in pediatric patients and young adults. Materials and 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%. Conclusion 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. [ABSTRACT FROM AUTHOR]