Clinical Trial: Imaging of Osteonecrosis With Ferumoxytol-Enhanced MRI

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Imaging of Osteonecrosis With Ferumoxytol-Enhanced MRI

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

Detailed Summary:

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.


Sponsor: Stanford University

Current Primary Outcome: Evaluation of treatment response to decompression surgery and stem cell transplant [ Time Frame: one year ]

Evaluation of progression of osteonecrosis via scale 1-4, bone marrow edema, collapse of subchondral fractures.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Stanford University

Dates:
Date Received: July 27, 2016
Date Started: May 2015
Date Completion: July 2018
Last Updated: September 2, 2016
Last Verified: September 2016