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Completed

NCT Number: NCT02893293

Imaging of Osteonecrosis With Ferumoxytol-Enhanced MRI

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

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Key information

Conditions

Osteonecrosis Bone Diseases Musculoskeletal Diseases Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

8 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Lucile Packard Children's Hospital

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ferumoxytol-enhanced magnetic resonance imaging

Drug

Eligible patients receive a single ferumoxytol-dose and follow-up magnetic resonance imaging to evaluate success of stem cell transplant

Magentic Resonance Imaging

Device

Both arms will receive MRI

Other names: MRI

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Acronym: Osteonecro

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
Sep 8, 2016
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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