Early Assessment of Tumor Response to Therapy Using Ferumoxytol (Code 7228) as an MR Contrast Agent in Patients With Glioblastoma Multiforme
Patients will be scanned at four time-points of their radiation/temozolomide treatment:
before onset of radiation/temozolomide treatment, at 3 weeks, 6 weeks and 12 weeks
following the onset of treatment. Each time-point will consist of 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 (1 mg/kg). On
the third day: MRI without additional contrast agent, 24 hr post ferumoxytol infusion. There
will be follow up visits 1 month and 6 months after the last ferumoxytol injection.
The ferumoxytol molecule contains iron-oxide and other components (carbohydrate), which
makes ferumoxytol safe for short and fast (bolus) injections. This new contrast agent has
not shown significant side effects, even using extremely high doses in animal experiments. A
total of 516 human subjects have received one or more doses of ferumoxytol. There have been
3 cases with serious side effects possibly related to the administration of ferumoxytol. Two
cases of peritonitis (the inflammation of the lining the abdomen) that were possibly related
and one case of anaphylaxis (serious allergic reaction) related to ferumoxytol. (Of note is
that gadolinium, the standard contrast agent, carries a serious risk for persons with kidney
dysfunction. This risk is the condition called nephrogenic systemic fibrosis (NSF), which
causes scar tissue to develop and can, in some cases, affect internal organs and even lead
to death.)
The various types of MR measurement (Perfusion, blood-brain barrier permeability, diffusion)
will be evaluated or measured at each time-point, for each contrast agent. Certain regions
will be described and the data will be evaluated throughout the study in an attempt to
correlate changes with tumor response to therapy. 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).
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
To characterize GBM tumor vascular properties using Ferumoxytol and compare to those obtained using Gd based MRI contrast agent.
12 weeks
No
Edward A Neuwelt, MD
Principal Investigator
Oregon Health and Science University
United States: Institutional Review Board
OHSU-2753
NCT00660543
October 2006
March 2014
Name | Location |
---|---|
Oregon Health & Science University | Portland, Oregon 97201 |