Ferumoxytol - Iron Oxide Nanoparticle Magnetic Resonance Dynamic Contrast Enhanced MRI

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.

Inclusion Criteria:

1. Patients 18 years of age or older with histologically or cytologically confirmed head
and neck squamous cell carcinoma or melanoma

2. Measurable clinical and/or radiographic poly-nodal disease defined as stage N2b, N2c
or N3 disease with multiple involved lymph nodes as defined by the American Joint
Committee on Cancer (AJCC) cancer staging criteria

3. Patients who have received or are dispositioned to receive a Positron emission
tomography (PET) and computerized tomography (CT) [PET-CT] scan within two weeks of
starting definitive therapy for their head and neck malignancy and their participation
in this study. This implies patients must receive a PET-CT to be eligible for the
study.

Exclusion Criteria:

1. Patients who have undergone definitive resection of their primary or nodal disease as
well as any chemotherapy or radiation therapy for their head and neck primary tumor.

2. Patients unable or unwilling to give written, informed consent or to undergo MRI
imaging.

3. Women of childbearing potential (A woman of child-bearing potential is a sexually
mature woman who has not undergone a hysterectomy or who has not been naturally
postmenopausal for at least 24 consecutive months [i.e., who has had menses at any
time in the preceding 24 consecutive months]). Male partners must practice effective
contraception (oral, injectable, or implantable hormonal contraceptive; tubal
ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized
partner) throughout the study.

4. Patients unable to tolerate DCE-MRI or having an estimated GFR < 60 ml/min/1.73m^2.

5. Contraindications to iron supplementation include hemochromatosis, colitis, history of
GI bleeds, alcoholism, or liver disease. Ferumoxytol is contraindicated in patients
with evidence of iron overload and/or known hypersensitivity to Feraheme or any of its
components. Consequently, we will plan to exclude patients who have symptoms or signs
that might be caused by iron overload. These include patients with (unexplained):
arthritis (including premature osteoarthritis), congestive heart failure or
cardiomyopathy, adult-onset diabetes, secondary hypogonadism, increased skin
pigmentation, or patients with persistently elevated serum ferritin not explained by
an underlying inflammatory/systemic disease, unless these patients demonstrate a
fasting transferrin saturation
6. Patients with any evidence of iron overload on pre-imaging laboratory studies.

7. Patients with any contraindications to gadolinium-based contrast agents.

8. Patients with claustrophobia.