Imaging of Osteonecrosis With Ferumoxytol-Enhanced MRI

Stanford University

Status and phase: Completed; Phase 4

Conditions: Osteonecrosis

Treatments: Device: Magentic Resonance Imaging; Drug: Ferumoxytol-enhanced magnetic resonance imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT02893293

IRB-20253(osteonecrosis)

PEDSBONE0006 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 8 to 40 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Ferumoxytol-enhanced MRI

Active Comparator group

Description:

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.

Treatment:

Drug: Ferumoxytol-enhanced magnetic resonance imaging

Device: Magentic Resonance Imaging

Non-ferumoxytol enhanced MRI

Sham Comparator group

Description:

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.

Treatment:

Device: Magentic Resonance Imaging