Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
14 participants
INTERVENTIONAL
2015-05-31
2023-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
FACTORIAL
DIAGNOSTIC
NONE
Study Groups
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Ferumoxytol-enhanced MRI
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.
Ferumoxytol-enhanced magnetic resonance imaging
Eligible patients receive a single ferumoxytol-dose and follow-up magnetic resonance imaging to evaluate success of stem cell transplant
Magentic Resonance Imaging
Both arms will receive MRI
Non-ferumoxytol enhanced MRI
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.
Magentic Resonance Imaging
Both arms will receive MRI
Interventions
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Ferumoxytol-enhanced magnetic resonance imaging
Eligible patients receive a single ferumoxytol-dose and follow-up magnetic resonance imaging to evaluate success of stem cell transplant
Magentic Resonance Imaging
Both arms will receive MRI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* planned decompression surgery with autologous stem cell transplant
Exclusion Criteria
* Hemosiderosis/hemochromatosis ( patients can still be included in the non-ferumoxytol arm)
8 Years
40 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Heike E Daldrup-Link
Professor of Radiology
Principal Investigators
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Heike Daldrup-Link, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Lucile Packard Children's Hospital
Stanford, California, United States
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Pediatric Molecular Imaging Program
Other Identifiers
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PEDSBONE0006
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-20253(osteonecrosis)
Identifier Type: -
Identifier Source: org_study_id
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