Imaging of Osteonecrosis With Ferumoxytol-Enhanced MRI (Osteonecro)

October 31, 2024 updated by: Heike E Daldrup-Link, Stanford University
The goal of the project is to evaluate osteonecrosis before and after decompression surgery with ferumoxytol-enhanced MRI.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Lucile Packard Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ferumoxytol-enhanced MRI
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.
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
Other Names:
  • MRI
Sham Comparator: Non-ferumoxytol enhanced MRI
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.
Device: Magentic Resonance Imaging
Both arms will receive MRI
Other Names:
  • MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Signal to Noise Ratio (SNR)
Time Frame: week 1 postsurgery

SNR is a measurement that compares the strength of a signal to the level of background noise. It is often expressed in decibels (dB) and is calculated by dividing the signal power by the noise power. A ratio greater than 1:1 indicates that there is more signal than noise.

First, for each lesion the MR signal intensity (SI) of the lesion and the SI of the background (= noise in the image) was measured, then the SI of the lesion was divided by the SI of the noise to obtain the signal to noise ratio. Then, the mean SNR and standard deviation was calculated for the different groups of lesions and compared to the mean SNR between treated versus not treated lesions and treated lesions at different time points after the treatment using statistical tests.
week 1 postsurgery
T2*-Relaxation Time
Time Frame: week 1 postsurgery
T2* relaxation time is a measure of how quickly transverse magnetization decays in magnetic resonance imaging (MRI). It's a key factor in image contrast in gradient-echo (GRE) sequences and is used in many MRI applications, such as perfusion imaging, susceptibility-weighted imaging, and functional imaging. Lower T2* relaxation times indicate greater contrast agent uptake in cells.
week 1 postsurgery
Evaluation of Treatment Response to Decompression Surgery and Stem Cell Transplant
Time Frame: one year
Number of femurs that did not collapse by 1 year follow up. Evaluation of progression of osteonecrosis via scale 1-4, bone marrow edema, collapse of subchondral fractures.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Heike Daldrup-Link, MD, PhD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

October 31, 2023

Study Completion (Actual)

October 31, 2023

Study Registration Dates

First Submitted

July 27, 2016

First Submitted That Met QC Criteria

September 2, 2016

First Posted (Estimated)

September 8, 2016

Study Record Updates

Last Update Posted (Actual)

November 26, 2024

Last Update Submitted That Met QC Criteria

October 31, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-20253(osteonecrosis)
  • PEDSBONE0006 (Other Identifier: OnCore)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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