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Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

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Iron

Ferrosoferric Oxide

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On Day 1, patient will have 2 standard MRIs, as part of standard of care. About an hour after these 2 scans, patient receives ferumoxytol by vein. Right after that, first study MRI performed. The study MRI performed in the same way that a standard MRI is performed.

On Day 2, about 24 hours after patient receives ferumoxytol, second study MRI performed.

On Day 1, patient will have 2 standard MRIs, as part of standard of care. About an hour after these 2 scans, patient receives ferumoxytol by vein. Right after that, first study MRI performed. On Day 2, about 24 hours after patient receives ferumoxytol, second study MRI performed.

Magnetic Resonance Imaging (MRI)

On Day 1, patient will have 2 standard MRIs, as part of standard of care. About an hour after these 2 scans, patient receives ferumoxytol by vein.

Ferumoxytol

Clifton Fuller, MD

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.

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.

Ferumoxytol - Iron Oxide Nanoparticle Magnetic Resonance Dynamic Contrast Enhanced MRI

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

Feasibility defined as at least 15 (75%) patients finish the imaging process and good quality images obtained. Good quality image defined as subjective quality assessment score of 4 by two independent radiation oncologists and one radiologist for clinical usability for radiotherapy planning on a 5-point scale. The 5-point scale is defined with 0 implying unable to assess and 5 implying optimal image quality.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ferumoxytol - Iron Oxide Nanoparticle Magnetic Resonance Dynamic Contrast Enhanced MRI	NCT01895829	Head and Neck C...	Magnetic Resona... Ferumoxytol	18 Years -	M.D. Anderson Cancer Center
Ferumoxytol - Iron Oxide Nanoparticle Magnetic Resonance Dynamic Contrast Enhanced MRI	NCT01895829	Head and Neck C...	Magnetic Resona... Ferumoxytol	18 Years -	M.D. Anderson Cancer Center
Ferumoxytol - Iron Oxide Nanoparticle Magnetic Resonance Dynamic Contrast Enhanced MRI	NCT01895829	Head and Neck C...	Magnetic Resona... Ferumoxytol	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for dynamic contrast imaging