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
• 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
• 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)

Related Conditions & MeSH terms

• Osteonecrosis

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

External Links

•   Pediatric Molecular Imaging Program