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NCT02893293 Clinical Trial

Imaging of Osteonecrosis With Ferumoxytol-Enhanced MRI

Osteonecrosis Clinical Trial

— Osteonecro  

Official title:
Imaging of Osteonecrosis With Ferumoxytol-Enhanced MRI

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT02893293
Other study ID # IRB-20253(osteonecrosis)
Secondary ID PEDSBONE0006
Status Enrolling by invitation
Phase Phase 4
First received
Last updated
Start date May 2015
Est. completion date December 2023

Study information
Verified date May 2023
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
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)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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
Device:
• Magentic Resonance Imaging
Both arms will receive MRI

Locations
Country Name City State
United States Lucile Packard Children's Hospital Stanford California

Sponsors (1)
Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

Outcome
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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