Imaging of Osteonecrosis With Ferumoxytol-Enhanced MRI
Status: | Recruiting |
---|---|
Conditions: | Orthopedic |
Therapuetic Areas: | Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 8 - 40 |
Updated: | 12/13/2018 |
Start Date: | May 2015 |
End Date: | July 2020 |
Contact: | Anne Muehe, MD |
Email: | amuehe@stanford.edu |
Phone: | 650 497 8601 |
The goal of the project is to evaluate osteonecrosis before and after decompression surgery
with ferumoxytol-enhanced MRI.
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.
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.
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)
We found this trial at
1
site
Stanford, California 94305
Principal Investigator: Heike E Daldrup-Link, MD, PhD
Phone: 650-720-8601
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