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Ferumoxytol - Iron Oxide Nanoparticle Magnetic Resonance Dynamic Contrast Enhanced MRI

Head and Neck Cancer Clinical Trial

Official title:
Pilot Feasibility Study of Iron Oxide Nanoparticle Magnetic Resonance Dynamic Contrast Enhanced MRI for Primary and Nodal Tumor Imaging in Locally Advanced Head and Neck Squamous Cell Carcinomas

Clinical Trial Summary

The goal of this clinical research study is to learn if ferumoxytol, when given at the time of a magnetic resonance imaging (MRI), can help researchers learn more about the spread of certain kinds of cancers. Ferumoxytol is designed to deliver iron to treat iron-deficiency anemia (low red blood cell counts) in patients with chronic kidney disease. In this study, it will be used as an MRI contrast. Contrasts are used by doctors in order to see MRI images more clearly.

Clinical Trial Description

Study Scans: If you are found to be eligible to take part in this study, you will have 2 study MRIs. These scans will be performed at the Center for Advanced Biomedical Imaging (CABI), in the South Campus Research Building at MD Anderson. On Day 1, you will have 2 standard MRIs, as part of your standard of care. About an hour after these 2 scans, you will receive ferumoxytol by vein. Right after that, you will have your first study MRI. The study MRI will be performed in the same way that a standard MRI is performed. On Day 2, about 24 and 72 hours after you receive ferumoxytol, you will have a second study MRI. Additional Tests: On Days 1 and 3, as well as 4 weeks after the first study MRI: - You will have a physical exam. - Blood (about 2 teaspoons) will be drawn for routine tests and/or to check your iron level. On Day 2: - You will have a physical exam. - If you have not had one in the last month, you will have a PET-CT scan to check the status of the disease. Length of Study: You will be on study for about 4 weeks. You will be taken off study if you have intolerable side effects or you are unable to have the scans for any reason. This is an investigational study. Ferumoxytol is commercially available and FDA-approved for the treatment of iron deficiency anemia. Up to 20 patients will take part in this study. All will be enrolled at MD Anderson. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01895829
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Terminated
Phase Early Phase 1
Start date September 12, 2013
Completion date September 7, 2021
View Details
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