Imaging of Osteonecrosis With Ferumoxytol-Enhanced MRI

Study Overview
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Brief Summary
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The goal of the project is to evaluate osteonecrosis before and after decompression surgery with ferumoxytol-enhanced MRI.

Detailed Description
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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.

Official Title
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Imaging of Osteonecrosis With Ferumoxytol-Enhanced MRI

Conditions
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Osteonecrosis

Intervention / Treatment
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* Drug: Ferumoxytol-enhanced magnetic resonance imaging
* Device: Magentic Resonance Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Osteonecrosis planned decompression surgery with autologous stem cell transplant Exclusion Criteria: Contraindications for magnetic resonance imaging Hemosiderosis/hemochromatosis ( patients can still be included in the non-ferumoxytol arm)

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ferumoxytol-enhanced MRI<br>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. | Drug: Ferumoxytol-enhanced magnetic resonance imaging<br>* Eligible patients receive a single ferumoxytol-dose and follow-up magnetic resonance imaging to evaluate success of stem cell transplant<br>Device: Magentic Resonance Imaging<br>* Both arms will receive MRI<br>* Other names: MRI;|
| Sham Comparator: Non-ferumoxytol enhanced MRI<br>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. | Device: Magentic Resonance Imaging<br>* Both arms will receive MRI<br>* Other names: MRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of treatment response to decompression surgery and stem cell transplant | Evaluation of progression of osteonecrosis via scale 1-4, bone marrow edema, collapse of subchondral fractures. | one year |