Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI

PRIMARY OBJECTIVES:

I. Establish magnetic resonance (MR) imaging characteristics of bone sarcomas and
osteomyelitis based on their ferumoxytol-enhancement on relatively early postcontrast
T1-weighted images.

II. Establish MR imaging characteristics of bone sarcomas and osteomyelitis based on their
ferumoxytol-enhancement on delayed postcontrast T2-weighted images.

III. Establish T2-weighted MR imaging characteristics of iron labeled mesenchymal stem cell
(MSC) in osteonecrotic bone over time, before and after surgical core decompression and bone
marrow implantation.

IV. Adding a second branch for patients who can not receive ferumoxytol but still getting the
MRI exam.

OUTLINE:

Patients receive ferumoxytol intravenously (IV) and then undergo ferumoxytol-enhanced MRI up
to 1 hour after infusion and up to 24 hours post-infusion.

Inclusion Criteria:

- Suspected or confirmed diagnosis of a bone sarcoma or osteomyelitis

- Symptomatic osteonecrosis (ON) of the femur or proximal tibia with MR signal
abnormalities that involve more than 50% of the respective joint surface, but no
evidence of epiphyseal collapse

- There will be no gender/race-ethnic restrictions

- In this pediatric & adult study, the participant or parent/guardian is consented, and
the patient when a minor is given an assent form and involved in the discussion as
appropriate

Exclusion Criteria:

- Contraindication to MRI

- Presence of metal implants

- Need for sedation or anesthesia

- Claustrophobia

- Hemosiderosis/hemochromatosis (patients can still be included in the 2nd branch
without receiving ferumoxytol)

- There will be no restrictions regarding use of other investigational agents

- Patients with evidence of iron overload, hemosiderosis/hemochromatosis will be
excluded for the bone sarcoma study; however, they can undergo MRI exam without
ferumoxytol enhancement for the ON study

- History of allergic reactions to similar compounds will be obtained and patients with
positive history of allergic reactions will be excluded from the study

- Pregnancy or nursing patients will be excluded from the study; a pregnancy test will
be done prior to the MR examination for postmenarchal teenage girls, in whom pregnancy
may be possible; only patients with a negative pregnancy test will be included in the
study