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Intravenous injection of Feraheme, 5 mg Fe/kg

5 mg/kg by intravenous (IV) administration

Feraheme

Standard of Care magnetic resonance imaging (MRI) scans using GE 1.5T and 3T MRI scanners/

Magnetic Resonance Imaging (MRI) scan

Heike E Daldrup-Link, MD

Neyssa Marina, MD

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.

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.

Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI

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

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.

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.

Differentiation of lymphoma from bone sarcoma was assessed as the difference of mean T2 \* relaxation time determined by ferumoxytol-enhanced MRI.

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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.

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.

Heike E Daldrup-Link

Professor of Radiology (General Radiology)

Intravenous injection of Feraheme, 5 mg Fe/kg

Feraheme: 5 mg Fe/kg iv

MR Scan: Standard of Care

Intravenous injection of Feraheme, 5 mg Fe/kg

Feraheme: 5 mg Fe/kg by intravenous adminstration

MR Scan: Standard of Care

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Heike Daldrup-Link

Participants with bone sarcomas (osteosarcomas and Ewing sarcomas) evaluated with ferumoxytol-enhanced MRI.

Bone Sarcomas

Participants with osteomyelitis evaluated with MRI with ferumoxytol enhancement.

This initial phase of the study was a pilot assessment of participants with bone sarcomas compared to participants with osteomyelitis.

T2* Relaxation Time of Bone Sarcomas and Osteomyelitis Subjects

Pre-treatment

Post-treatment

Participants with bone sarcomas (osteosarcomas and Ewing sarcomas) only.

Bone Sarcomas Pre-ferumoxytol & Post-ferumoxytol Contrast

Only the participants with bone sarcomas were evaluated for this outcome.

Differentiation of Bone Sarcomas Pre-ferumoxytol and Post-ferumoxytol Contrast

Participants with lymphoma evaluated with ferumoxytol-enhanced MRI

Mean T2 * Relaxation Time for Lymphoma Participants

Participants with bone sarcoma, evaluated with ferumoxytol-enhanced MRI

Mean T2 * Relaxation Time for Bone Sarcoma Participants

The analysis population for this outcome includes the participants with bone sarcoma who participated in the pilot study.

Differentiation of Lymphoma and Bone Sarcomas With Ferumoxytol-enhanced MRI

CD-68-positive tumor-associated macrophages (TAM) assessed in Lymphoma participants

Mean Area Density of CD-68-positive TAM in Lymphoma

CD-68-positive Tumor associated macrophages(TAMs)in Bone Sarcomas participants

Mean Area Density of CD-68-positive TAM in Bone Sarcomas

Differentiation of CD68-positive Tumor-associated Macrophages (TAM) in Lymphomas and Bone Sarcomas

CD163-positive tumor-associated macrophages (TAM) was assessed in participants with lymphoma

Mean Area Density of CD163-positive TAM in Lymphoma

CD163-positive tumor-associated macrophages (TAM) was assessed in participants with bone sarcomas

Spots Global Cancer Trial Database for bone necrosis