A Phase II Study of Ferumoxytol and Gadolinium Magnetic Resonance Imaging at 3T and 7T in Patients With Malignant Brain Tumors Either Before or After Therapy
Patients will be scanned either before or after treatment (radiation and/or chemotherapy).
There will be three visits on three consecutive days. On first day: MRI with and without
gadolinium (the usual MR contrast agent) infusion (0.1 mmol/kg). On second day: MRI with
ferumoxytol infusion (4 mg/kg). On the third day: MRI without additional contrast agent, 24
hr post ferumoxytol infusion. On the first and third day scans will be done in both magnets,
on the second day scans will be done either on 3T or 7T.
Various types of MR measurements (Perfusion, blood-brain barrier permeability, tumor volume)
will be measured using both contrast agents, in 3 and/or 7 Tesla. Certain regions will be
described and the data will be evaluated throughout the study. The tumor volume will be
evaluated by 2 radiologists, measuring the diameters of the largest areas of contrast
enhancement and signal intensities will be also compared (semi-quantitatively).
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
The primary objective of this project is to compare quantitative imaging measures of brain tumor vascularity obtained from 3 T and 7T MRI instruments
Edward A Neuwelt, MD
Oregon Health and Science University
United States: Food and Drug Administration
|Oregon Health & Science University||Portland, Oregon 97201|