12
Participants
Start Date
July 31, 2012
Primary Completion Date
April 30, 2015
Study Completion Date
April 30, 2016
Ferumoxytol
Ferumoxytol will be administered as an undiluted intravenous injection dose of 6 mg/kg body weight, up to a maximum dose of 510 mg, delivered at a rate of up to 1ml/sec. Each ml of the supplied agent contains 30 mg of elemental iron and the dose will be titrated based on patients body weight in kilograms; for example at a dose of 6 mg/kg, the dose for a 50 kg person will be 50 x 6 = 300 mg. As the vial contains 30 mg/ml, 10 cc of the dose will correspond to the required 300 mg dose.
Nanoparticle MRI
Each subject will have one MRI scan. At the initial pre-scan visit, the subject will receive the ferumoxytol infusion. Within 48-72 hours after ferumoxytol infusion, a scan will be performed. Subjects will be imaged at Massachusetts General Hospital using commercial 3.0T imaging systems using dedicated neck coil and approved imaging protocols. The MR imaging will include conventional T1 and T2 weighted spin echo and 3 D gradient echo sequences.
Massachusetts General Hospital, Boston
Massachusetts General Hospital
OTHER