Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI

Study Overview
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Brief Summary
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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
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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 theeffective 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.

Official Title
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Pilot Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI

Conditions
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Rhabdomyosarcoma, Bone Cancer, Chondrosarcoma, Ewing's Sarcoma, Osteosarcoma, Bone Necrosis, Bone Sarcoma, Osteomyelitis

Intervention / Treatment
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* Drug: Feraheme
* Procedure: Magnetic Resonance Imaging (MRI) scan


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA Age 10 to 21 years Suspected or confirmed diagnosis of a bone sarcoma or osteomyelitis Informed consent with assent as appropriate. EXCLUSION CRITERIA Contraindication to MRI Presence of metal implants Need for sedation or anesthesia Claustrophobia Hemosiderosis or hemochromatosis History of allergic reactions to similar compounds will be obtained and patients with positive history of allergic reactions will be excluded from the study Females who are pregnancy or nursing

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Feraheme<br>Intravenous injection of Feraheme, 5 mg Fe/kg | Drug: Feraheme<br>* 5 mg/kg by intravenous (IV) administration<br>* Other names: ferumoxytol;Procedure: Magnetic Resonance Imaging (MRI) scan<br>* Standard of Care magnetic resonance imaging (MRI) scans using GE 1.5T and 3T MRI scanners/<br>* Other names: Magnetic Resonance (MR) scan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T2* Relaxation Time of Bone Sarcomas and Osteomyelitis Subjects | Differentiation of bone sarcomas and osteomyelitis with ferumoxytol-enhanced magnetic resonance imaging (MRI) was assessed as the difference of mean T2 * relaxation time of bone sarcoma and osteomyelitis subjects. The outcome is reported as the difference of the mean T2 * values, with standard deviation. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differentiation of Bone Sarcomas Pre-ferumoxytol and Post-ferumoxytol Contrast | Differentiation of bone sarcomas pre-ferumoxytol and post-ferumoxytol contrast was assessed by difference of mean T2 * relaxation time pre-ferumoxytol and post-ferumoxytol contrast, in bone sarcoma subjects only. | Baseline and Post-Treatment-24 hours | 
| Differentiation of Lymphoma and Bone Sarcomas With Ferumoxytol-enhanced MRI | Differentiation of lymphoma from bone sarcoma was assessed as the difference of mean T2 * relaxation time determined by ferumoxytol-enhanced MRI. . | 24 hours | 
| Differentiation of CD68-positive Tumor-associated Macrophages (TAM) in Lymphomas and Bone Sarcomas | Differentiation of CD68-positive tumor-associated macrophages (TAM) between lymphoma and bone sarcoma was assessed as the difference of mean area density of CD68-positive TAM in those populations. | 24 hours | 
| Differentiation of CD163-positive Tumor-associated Macrophages (TAM) in Lymphomas and Bone Sarcomas | Differentiation of CD163-positive tumor-associated macrophages (TAM) between lymphoma and bone sarcoma was assessed as the difference of mean area density of CD163-positive TAM in those populations. | 24 hours |