Clinical trial NCT02893293: Imaging of Osteonecrosis With Ferumoxytol-Enhanced MRI
Official title: Imaging of Osteonecrosis With Ferumoxytol-Enhanced MRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteonecrosis
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 14
Sex: ALL
Minimum age (years): 8
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

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

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Signal to Noise Ratio (SNR)
timeFrame: week 1 postsurgery
measure: T2*-Relaxation Time
timeFrame: week 1 postsurgery
measure: Evaluation of Treatment Response to Decompression Surgery and Stem Cell Transplant
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Lucile Packard Children's Hospital
state: California
Study officials:
affiliation: Stanford University
name: Heike Daldrup-Link, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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. doi: 10.1158/1078-0432.CCR-18-1687. Epub 2018 Sep 17.