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| ID | Type | Description | Link |
|---|---|---|---|
| PEDSBONE0006 | Other Identifier | OnCore |
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The goal of the project is to evaluate osteonecrosis before and after decompression surgery with ferumoxytol-enhanced MRI.
The goal of the project is to evaluate osteonecrosis before and after decompression surgery with ferumoxytol-enhanced MRI.
The investigators approach relies on the FDA-approved iron supplement ferumoxytol (Feraheme), which is used off label as a contrast agent for MRI. Ferumoxytol is composed of iron oxide nanoparticles, which provide a strong T1- and T2-signal on magnetic resonance (MR) images and are taken up by cells in bone marrow.
20 patients will undergo MRI before and after decompression surgery and transplantation of bone marrow derived cells. 10 patients will receive a single intravenous injection of ferumoxytol prior to their surgery. 10 additional patients will serve as untreated controls. The investigators hypothesize that MR images after intravenous injection of ferumoxytol will improve lesion detection and allow to track transplanted bone marrow cells. MR imaging findings will be correlated with clinical outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferumoxytol-enhanced MRI | Active Comparator | Patients receive a ferumoxytol injection (Feraheme, AMAG, 5mg Fe/kg, single administration) prior to routine decompression surgery and autologous stem cell transplant. Follow-up imaging with magnetic resonance imaging will be conducted in regular intervals for evaluation of the response to treatment. |
|
| Non-ferumoxytol enhanced MRI | Sham Comparator | Patients scheduled for routine decompression surgery and autologous stem cell transplant will receive follow-up magnetic resonance imaging in regular intervals for evaluation of the response to treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferumoxytol-enhanced magnetic resonance imaging | Drug | Eligible patients receive a single ferumoxytol-dose and follow-up magnetic resonance imaging to evaluate success of stem cell transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Signal to Noise Ratio (SNR) | SNR is a measurement that compares the strength of a signal to the level of background noise. It is often expressed in decibels (dB) and is calculated by dividing the signal power by the noise power. A ratio greater than 1:1 indicates that there is more signal than noise. First, for each lesion the MR signal intensity (SI) of the lesion and the SI of the background (= noise in the image) was measured, then the SI of the lesion was divided by the SI of the noise to obtain the signal to noise ratio. Then, the mean SNR and standard deviation was calculated for the different groups of lesions and compared to the mean SNR between treated versus not treated lesions and treated lesions at different time points after the treatment using statistical tests. | week 1 postsurgery |
| T2*-Relaxation Time | T2* relaxation time is a measure of how quickly transverse magnetization decays in magnetic resonance imaging (MRI). It's a key factor in image contrast in gradient-echo (GRE) sequences and is used in many MRI applications, such as perfusion imaging, susceptibility-weighted imaging, and functional imaging. Lower T2* relaxation times indicate greater contrast agent uptake in cells. | week 1 postsurgery |
| Evaluation of Treatment Response to Decompression Surgery and Stem Cell Transplant | Number of femurs that did not collapse by 1 year follow up. Evaluation of progression of osteonecrosis via scale 1-4, bone marrow edema, collapse of subchondral fractures. | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heike Daldrup-Link, MD, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucile Packard Children's Hospital | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26656202 | Background | Muehe AM, Feng D, von Eyben R, Luna-Fineman S, Link MP, Muthig T, Huddleston AE, Neuwelt EA, Daldrup-Link HE. Safety Report of Ferumoxytol for Magnetic Resonance Imaging in Children and Young Adults. Invest Radiol. 2016 Apr;51(4):221-227. doi: 10.1097/RLI.0000000000000230. | |
| 27174199 | Background | Nejadnik H, Lenkov O, Gassert F, Fretwell D, Lam I, Daldrup-Link HE. Macrophage phagocytosis alters the MRI signal of ferumoxytol-labeled mesenchymal stromal cells in cartilage defects. Sci Rep. 2016 May 13;6:25897. doi: 10.1038/srep25897. |
| Label | URL |
|---|---|
| Pediatric Molecular Imaging Program | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ferumoxytol-enhanced MRI | Patients scheduled for routine decompression surgery and autologous stem cell transplant receive ferumoxytol injection (Feraheme, AMAG, 5mg Fe/kg, single administration), and follow-up magnetic resonance imaging in regular intervals for evaluation of the response to treatment. |
| FG001 | Non-ferumoxytol Enhanced MRI | Patients scheduled for routine decompression surgery and autologous stem cell transplant receive follow-up magnetic resonance imaging in regular intervals for evaluation of the response to treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ferumoxytol-enhanced MRI | Patients scheduled for routine decompression surgery and autologous stem cell transplant receive ferumoxytol injection (Feraheme, AMAG, 5mg Fe/kg, single administration), and follow-up magnetic resonance imaging in regular intervals for evaluation of the response to treatment. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Signal to Noise Ratio (SNR) | SNR is a measurement that compares the strength of a signal to the level of background noise. It is often expressed in decibels (dB) and is calculated by dividing the signal power by the noise power. A ratio greater than 1:1 indicates that there is more signal than noise. First, for each lesion the MR signal intensity (SI) of the lesion and the SI of the background (= noise in the image) was measured, then the SI of the lesion was divided by the SI of the noise to obtain the signal to noise ratio. Then, the mean SNR and standard deviation was calculated for the different groups of lesions and compared to the mean SNR between treated versus not treated lesions and treated lesions at different time points after the treatment using statistical tests. | Participants who completed the protocol | Posted | Mean | Standard Deviation | dB | week 1 postsurgery |
|
1 week period (20 minute treatment and 1 week follow-up) plus follow-up visits for approximately 1 year
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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 | Ferumoxytol-enhanced MRI | Patients scheduled for routine decompression surgery and autologous stem cell transplant receive ferumoxytol injection (Feraheme, AMAG, 5mg Fe/kg, single administration), and follow-up magnetic resonance imaging in regular intervals for evaluation of the response to treatment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heike Daldrup-Link, MD | Stanford University | (650) 725-2548 | mairead@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 11, 2023 | Oct 30, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 20, 2023 | Mar 18, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010020 | Osteonecrosis |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
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| Magentic Resonance Imaging | Device | Both arms will receive MRI |
|
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| 30224340 | Result | Theruvath AJ, Nejadnik H, Muehe AM, Gassert F, Lacayo NJ, Goodman SB, Daldrup-Link HE. Tracking Cell Transplants in Femoral Osteonecrosis with Magnetic Resonance Imaging: A Proof-of-Concept Study in Patients. Clin Cancer Res. 2018 Dec 15;24(24):6223-6229. doi: 10.1158/1078-0432.CCR-18-1687. Epub 2018 Sep 17. |
| Non-ferumoxytol Enhanced MRI |
Patients scheduled for routine decompression surgery and autologous stem cell transplant receive follow-up magnetic resonance imaging in regular intervals for evaluation of the response to treatment. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Patients scheduled for routine decompression surgery and autologous stem cell transplant receive ferumoxytol injection (Feraheme, AMAG, 5mg Fe/kg, single administration), and follow-up magnetic resonance imaging in regular intervals for evaluation of the response to treatment.
| OG001 | Non-ferumoxytol Enhanced MRI | Patients scheduled for routine decompression surgery and autologous stem cell transplant receive follow-up magnetic resonance imaging in regular intervals for evaluation of the response to treatment. |
|
|
|
| Primary | T2*-Relaxation Time | T2* relaxation time is a measure of how quickly transverse magnetization decays in magnetic resonance imaging (MRI). It's a key factor in image contrast in gradient-echo (GRE) sequences and is used in many MRI applications, such as perfusion imaging, susceptibility-weighted imaging, and functional imaging. Lower T2* relaxation times indicate greater contrast agent uptake in cells. | Participants who completed the protocol | Posted | Mean | Standard Deviation | milliseconds | week 1 postsurgery |
|
|
|
|
| Primary | Evaluation of Treatment Response to Decompression Surgery and Stem Cell Transplant | Number of femurs that did not collapse by 1 year follow up. Evaluation of progression of osteonecrosis via scale 1-4, bone marrow edema, collapse of subchondral fractures. | Long-term follow up was conducted in the ferumoxytol group only | Posted | Count of Units | Femur | one year | Femur | Femur |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Non-ferumoxytol Enhanced MRI | Patients scheduled for routine decompression surgery and autologous stem cell transplant receive follow-up magnetic resonance imaging in regular intervals for evaluation of the response to treatment. | 0 | 5 | 0 | 5 | 0 | 5 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |