Neoplasms

All Conditions

Symptoms and General Pathology

Musculoskeletal Diseases

Infections

Skin and Connective Tissue Diseases

Rare Diseases

Sarcoma

Necrosis

Osteonecrosis

Osteomyelitis

Osteosarcoma

Sarcoma, Ewing

Chondrosarcoma

Bone Neoplasms

Rhabdomyosarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Myosarcoma

Communicable Diseases

Bone Diseases

Bone Diseases, Infectious

Soft Tissue Sarcoma

Ewing Sarcoma

Hematinics

Pharmaceutical Solutions

All Drugs and Chemicals

Ferrosoferric Oxide

Parenteral Nutrition Solutions

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

Mean Area Density of CD163-positive TAM in Bone Sarcoma

Differentiation of CD163-positive Tumor-associated Macrophages (TAM) in Lymphomas and Bone Sarcomas

Overall Study

Nervous System Diseases

Behaviors and Mental Disorders

Heart and Blood Diseases

Wounds and Injuries

Dementia

Heart Diseases

Hyperthermia

Fever

Vasculitis

Fever of Unknown Origin

Vascular Diseases

Body Temperature Changes

Patients undergo PET-CT over approximately 30 minutes and PET-MRI over approximately 45-90 minutes.

positron emission tomography

computed tomography

magnetic resonance imaging

Pablo Ros, MD, MPH, PhD

This randomized pilot clinical trial studies how well positron emission tomography (PET)-magnetic resonance imaging (MRI) works compared to standard-of-care PET-computed tomography (CT) in diagnosing patients with cancer, cardiac diseases, or neurologic diseases. PET-MRI combines two imaging methods that can be used to evaluate disease. PET-MRI is similar to standard-of-care PET-CT, but exposes the patient to less radiation. It is not yet known whether PET-MRI produces better image quality than PET-CT in diagnosing patients with cancer, cardiac disease, or neurologic disease.

PRIMARY OBJECTIVES:

I. To assess and optimize image quality of PET and MRI focusing on technical artifacts and their correction.

II. To assess the accuracy of PET quantification based on MR attenuation correction (MRAC) derived from various MRI sequences and reconstruction algorithms including the effect of routinely used Gadolinium-based contrast agents on MRAC.

III. To determine the clinical and diagnostic accuracy of PET-MRI in comparison to standard-of-care diagnostic imaging.

IV. To assess the efficacy and workflow in combining PET and MRI in one single examination as compared to separate imaging studies.

V. To assess the potential for radiation dose reduction if PET-CT is substituted by PET-MRI, thus avoiding the radiation exposure from the CT-component.

PET-MRI in Diagnosing Patients With Cancer, Cardiac Diseases, or Neurologic Diseases

PET-MRI: Evaluation, Optimization and Clinical Implementation

Overall image quality scores obtained from the two imaging modalities will be compared with the hypothesis that hybrid PET-MRI images is as good as PET-CT images or superior (not inferior) to the PET-CT images. Evaluation of overall image quality will be assessed using the following criteria: 1=excellent, 2=good, 3=acceptable, 4=poor, 5=not acceptable. A Wilcoxon (Mann-Whitney) rank-sum test with a 0.100 significance level will be used.

Lesion based SUV will be estimated and compared for PET-MR and PET-CT images in normal organs and compared. A two-sided two-sample t-test will be used to show significance of difference.

A two-sided z-test will be used to detect the difference in the area under the curve showing the sensitivity, specificity, positive and negative predictive values as well as accuracy of diagnostic information.

Statistical difference in time between PET-MRI versus sequential approach for PET-CT plus MRI. Workflow with shortest timely efforts and sufficient diagnostic information will be established as routine procedure.

Dose measurements will be used to calculate effective radiation dose in each patient. Dose calculations of effective dose will be used to estimate dose savings in omitting the CT component of PET-CT. Statistical tests will use a 0.10 significance level and will be 2-sided

National Cancer Institute (NCI)

Case Comprehensive Cancer Center

Patients undergo PET-CT over approximately 30 minutes and PET-MRI over approximately 45-90 minutes.

positron emission tomography: Undergo PET

computed tomography: Undergo CT

magnetic resonance imaging: Undergo MRI

PET-CT and PET-MRI

10-19 years

20-29 years

30-39 years

40-49 years

50-59 years

60-69 years

70-79 years

80-89 years

Age, Customized

No data was obtained from this study group as the patient cohort was inconsistent

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI	NCT01336803	Bone Cancer Chondrosarcoma Ewing's Sarcoma Osteosarcoma Rhabdomyosarcom... Bone Necrosis Bone Sarcoma Osteomyelitis	Feraheme Magnetic Resona...	10 Years - 21 Years	Stanford University
PET-MRI in Diagnosing Patients With Cancer, Cardiac Diseases, or Neurologic Diseases	NCT02084147	Cardiac Disease Dementia Inflammatory Di... Fever of Unknow... Vasculitis Osteomyelitis FDG Avid Cancer...	positron emissi... computed tomogr... magnetic resona...	18 Years -	Case Comprehensive Cancer Center

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