Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI
Condition: Bone Cancer; Chondrosarcoma; Ewing's Sarcoma; Osteosarcoma; Rhabdomyosarcoma; Bone Necrosis; Bone Sarcoma; Osteomyelitis
MeSH terms: Osteomyelitis; Sarcoma; Osteosarcoma; Rhabdomyosarcoma; Sarcoma, Ewing; Chondrosarcoma; Bone Neoplasms; Osteonecrosis; Necrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This pilot trial studies the differentiation of bone sarcomas and osteomyelitis with
      ferumoxytol-enhanced magnetic resonance imaging (MRI). Imaging procedures that allow doctors
      to more accurately differentiate between malignant bone sarcomas and osteomyelitis may help
      in diagnosing patients correctly and may result in more timely treatment.
    

Detailed description: 
      BACKGROUND; In this study, T1, T2, and T2* represent parameters of magnetic resonance imaging
      (MRI).

      The T1 relaxation time, also known as the spin-lattice relaxation time, is a measure of how
      quickly the net magnetization vector (NMV) recovers to its ground state in the direction of
      B0. T1 is assessed immediately post-contrast. A T1-weighted image (T1WI ) is one of the basic
      pulse sequences in MRI and demonstrates differences in the T1 relaxation times of tissues. A
      T1WI relies upon the longitudinal relaxation of a tissue's net magnetization vector (NMV).

      T2 is a time constant for the decay of transverse magnetization arising from natural
      interactions at the atomic or molecular levels, and be considered the "natural" or "true" T2
      of the tissue. However, in any nuclear magnetic resonance (NMR) experiment, transverse
      magnetization decays much faster than would be predicted by natural atomic and molecular
      mechanisms. Accordingly, T2 * is the time constant for the decay of transverse magnetization
      as observed in a tissue during a MRI scan, and be considered the"effective T2" (represented
      as T2*). T2* is always ≤ T2. In this study, T2 * is assessed after 24 hours.

      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.

      PRIMARY OBJECTIVES:

        -  Establish magnetic resonance (MR) imaging characteristics of bone sarcomas and
           osteomyelitis based on their ferumoxytol-enhancement on relatively early post-contrast
           T1-weighted images.

        -  Establish MR imaging characteristics of bone sarcomas and osteomyelitis based on their
           ferumoxytol-enhancement on delayed postcontrast T2-weighted images.

        -  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.

        -  Adding a second branch for patients who can not receive ferumoxytol but still getting
           the MRI exam. These patients will server as controls.
    

Intervention name(s): Feraheme; Magnetic Resonance Imaging (MRI) scan
Intervention type(s): Drug; Procedure
Intervention description(s): 5 mg/kg by intravenous (IV) administration; Standard of Care magnetic resonance imaging (MRI) scans using GE 1.5T and 3T MRI scanners/
Other intervention name(s): ferumoxytol; Magnetic Resonance (MR) scan
Intervention MeSH terms: Ferrosoferric Oxide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic