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| Tracking Information | |||||||||
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| First Received Date ICMJE | April 10, 2008 | ||||||||
| Last Updated Date | July 24, 2009 | ||||||||
| Start Date ICMJE | October 2006 | ||||||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00660543 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Magnetic Resonance (MR) Imaging Study Using Ferumoxytol to Assess Early Tumor Response in Patients With Glioblastoma Multiforme | ||||||||
| Official Title ICMJE | Early Assessment of Tumor Response to Therapy Using Ferumoxytol (Code 7228) as an MR Contrast Agent in Patients With Glioblastoma Multiforme | ||||||||
| Brief Summary | In this study the investigators would like to find out how a new iron containing Magnetic Resonance Imaging (MRI) contrast agent, called "ferumoxytol" can help the investigators to assess at the beginning of a therapy if it is effective or not in the treatment of a brain tumor called Glioblastoma Multiforme (GBM). For this purpose, after intravenous ferumoxytol injection, special MR scans (called: dynamic perfusion, blood-brain barrier (BBB) permeability measurement) will be performed to see the vascular changes in the brain and tumor. |
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| Detailed Description | 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). |
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| Study Phase | Phase I | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Diagnostic, Open Label, Single Group Assignment | ||||||||
| Condition ICMJE | Diagnostic Imaging | ||||||||
| Intervention ICMJE | Drug: Ferumoxytol | ||||||||
| Study Arms / Comparison Groups | Experimental: 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 | ||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 12 | ||||||||
| Estimated Completion Date | December 2011 | ||||||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 75 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00660543 | ||||||||
| Responsible Party | Edward A. Neuwelt, MD, Oregon Health & Science University | ||||||||
| Study ID Numbers ICMJE | OHSU-2753, NCI 26XS293 | ||||||||
| Study Sponsor ICMJE | Oregon Health and Science University | ||||||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||
| Investigators ICMJE |
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| Information Provided By | Oregon Health and Science University | ||||||||
| Verification Date | July 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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