Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI (Osteosarcoma)
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|ClinicalTrials.gov Identifier: NCT01336803|
Recruitment Status : Completed
First Posted : April 18, 2011
Results First Posted : June 18, 2019
Last Update Posted : June 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Bone Cancer Chondrosarcoma Ewing's Sarcoma Osteosarcoma Rhabdomyosarcoma Bone Necrosis Bone Sarcoma Osteomyelitis||Drug: Feraheme Procedure: Magnetic Resonance Imaging (MRI) scan||Phase 2|
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.
Patients receive ferumoxytol intravenously (IV) and then undergo ferumoxytol-enhanced MRI up to 1 hour after infusion and up to 24 hours post-infusion.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI|
|Actual Study Start Date :||August 2011|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||October 2018|
Intravenous injection of Feraheme, 5 mg Fe/kg
5 mg/kg by intravenous (IV) administration
Other Name: ferumoxytol
Procedure: Magnetic Resonance Imaging (MRI) scan
Standard of Care magnetic resonance imaging (MRI) scans using GE 1.5T and 3T MRI scanners/
Other Name: Magnetic Resonance (MR) scan
- T2* Relaxation Time of Bone Sarcomas and Osteomyelitis Subjects [ Time Frame: 24 hours ]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 [ Time Frame: Baseline and Post-Treatment-24 hours ]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 and Bone Sarcomas With Ferumoxytol-enhanced MRI [ Time Frame: 24 hours ]
Differentiation of lymphoma from bone sarcoma was assessed as the difference of mean T2 * relaxation time determined by ferumoxytol-enhanced MRI.
- Differentiation of CD68-positive Tumor-associated Macrophages (TAM) in Lymphomas and Bone Sarcomas [ Time Frame: 24 hours ]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) in Lymphomas and Bone Sarcomas [ Time Frame: 24 hours ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01336803
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Heike E Daldrup-Link, MD||Stanford University|
|Principal Investigator:||Neyssa Marina, MD||Stanford University|