Primary Outcome Measures:
- To characterize GBM tumor vascular properties using Ferumoxytol and compare to those obtained using Gd based MRI contrast agent. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Comparison of Gd and Ferumoxytol contrast agents for assessing cerebral blood flow , mean transit time , and time-to-peak perfusion parameters, and evaluate if any of these perfusion parameters is promising for tracking GBM therapeutic response. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- To obtain qualitative assessment of tumor vascularity using time-of-flight(TOF) MR angiography techniques. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- To characterize changes in the apparent diffusion coefficient (ADC) of tumor water associated with standard radio/chemotherapy in GBM. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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).