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Imaging of Osteonecrosis With Ferumoxytol-Enhanced MRI (Osteonecro)

Primary Purpose

Osteonecrosis

Status
Enrolling by invitation
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ferumoxytol-enhanced magnetic resonance imaging
Magentic Resonance Imaging
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Osteonecrosis

Eligibility Criteria

8 Years - 40 Years (Child, Adult)All SexesDoes not accept 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)

Sites / Locations

  • Lucile Packard Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Ferumoxytol-enhanced MRI

Non-ferumoxytol enhanced MRI

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 27, 2016
Last Updated
May 15, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT02893293
Brief Title
Imaging of Osteonecrosis With Ferumoxytol-Enhanced MRI
Acronym
Osteonecro
Official Title
Imaging of Osteonecrosis With Ferumoxytol-Enhanced MRI
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 2015 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteonecrosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ferumoxytol-enhanced MRI
Arm Type
Active Comparator
Arm 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.
Arm Title
Non-ferumoxytol enhanced MRI
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Ferumoxytol-enhanced magnetic resonance imaging
Intervention Description
Eligible patients receive a single ferumoxytol-dose and follow-up magnetic resonance imaging to evaluate success of stem cell transplant
Intervention Type
Device
Intervention Name(s)
Magentic Resonance Imaging
Other Intervention Name(s)
MRI
Intervention Description
Both arms will receive MRI
Primary Outcome Measure Information:
Title
Evaluation of treatment response to decompression surgery and stem cell transplant
Description
Evaluation of progression of osteonecrosis via scale 1-4, bone marrow edema, collapse of subchondral fractures.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heike Daldrup-Link, MD, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lucile Packard Children's Hospital
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26656202
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.
Results Reference
background
PubMed Identifier
27174199
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.
Results Reference
background
PubMed Identifier
30224340
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.
Results Reference
result
Links:
URL
http://daldrup-link-lab.stanford.edu/
Description
Pediatric Molecular Imaging Program

Learn more about this trial

Imaging of Osteonecrosis With Ferumoxytol-Enhanced MRI

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