Osteonecrosis Clinical Trial
— OsteonecroOfficial title:
Imaging of Osteonecrosis With Ferumoxytol-Enhanced MRI
Verified date | May 2023 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of the project is to evaluate osteonecrosis before and after decompression surgery with ferumoxytol-enhanced MRI.
Status | Enrolling by invitation |
Enrollment | 20 |
Est. completion date | December 2023 |
Est. primary completion date | October 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 40 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Lucile Packard Children's Hospital | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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