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| ID | Type | Description | Link |
|---|---|---|---|
| SU-04062011-7666 | Other Identifier | Stanford University | |
| PEDSBONE0006 | Other Identifier | OnCore Number |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Feraheme | Experimental | Intravenous injection of Feraheme, 5 mg Fe/kg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feraheme | Drug | 5 mg/kg by intravenous (IV) administration |
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| 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 |
| 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 |
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INCLUSION CRITERIA
EXCLUSION CRITERIA
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| Name | Affiliation | Role |
|---|---|---|
| Heike E Daldrup-Link, MD | Stanford University | Principal Investigator |
| Neyssa Marina, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Feraheme | Intravenous injection of Feraheme, 5 mg Fe/kg Feraheme: 5 mg Fe/kg by intravenous adminstration MR Scan: Standard of Care |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Feraheme | Intravenous injection of Feraheme, 5 mg Fe/kg Feraheme: 5 mg Fe/kg by intravenous adminstration MR Scan: Standard of Care |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | This initial phase of the study was a pilot assessment of participants with bone sarcomas compared to participants with osteomyelitis. | Posted | Mean | Standard Deviation | milliseconds | 24 hours |
|
24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Feraheme | Intravenous injection of Feraheme, 5 mg Fe/kg Feraheme: 5 mg Fe/kg iv MR Scan: Standard of Care |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heike Daldrup-Link | Stanford University | 650-723-8996 | heiked@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 4, 2011 | May 2, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001859 | Bone Neoplasms |
| D002813 | Chondrosarcoma |
| D012512 | Sarcoma, Ewing |
| D012516 | Osteosarcoma |
| D012208 | Rhabdomyosarcoma |
| D010020 | Osteonecrosis |
| D010019 | Osteomyelitis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D052203 | Ferrosoferric Oxide |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005296 | Ferrous Compounds |
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| Magnetic Resonance Imaging (MRI) scan | Procedure | Standard of Care magnetic resonance imaging (MRI) scans using GE 1.5T and 3T MRI scanners/ |
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| 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 |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Participants with osteomyelitis evaluated with MRI with ferumoxytol enhancement. |
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| Secondary | 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. | Only the participants with bone sarcomas were evaluated for this outcome. | Posted | Mean | Standard Deviation | milliseconds | Baseline and Post-Treatment-24 hours |
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| Secondary | 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. . | The analysis population for this outcome includes the participants with bone sarcoma who participated in the pilot study. | Posted | Mean | Standard Deviation | milliseconds | 24 hours |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Percentage of CD68-positive TAM | 24 hours |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Percentage area of CD163-positive TAM | 24 hours |
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| D009372 |
| Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D012509 | Sarcoma |
| D018213 | Neoplasms, Bone Tissue |
| D009217 | Myosarcoma |
| D009379 | Neoplasms, Muscle Tissue |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001850 | Bone Diseases, Infectious |
| D007239 | Infections |
| D008903 |
| Minerals |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
|