Imaging of Osteonecrosis With Ferumoxytol-Enhanced MRI

NCT02893293 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: IRB-20253(osteonecrosis)PEDSBONE0006
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteonecrosis

Outcome Measures

Primary Outcomes (3)

• Signal to Noise Ratio (SNR)

  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

  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

  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

Study Arms (2)

Ferumoxytol-enhanced MRI

ACTIVE COMPARATOR

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; Device: Magentic Resonance Imaging

Non-ferumoxytol enhanced MRI

SHAM COMPARATOR

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

Interventions

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

Ferumoxytol-enhanced MRI

Magentic Resonance Imaging DEVICE

Both arms will receive MRI

Also known as: MRI

Ferumoxytol-enhanced MRI; Non-ferumoxytol enhanced MRI

Eligibility Criteria

• Age: 8 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Osteonecrosis
• planned decompression surgery with autologous stem cell transplant

You may not qualify if:

• Contraindications for magnetic resonance imaging
• Hemosiderosis/hemochromatosis ( patients can still be included in the non-ferumoxytol arm)

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Packard Children's Hospital

Stanford, California, 94305, United States

Location

Related Publications (3)

• 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.

  PMID: 26656202 BACKGROUND

• 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.

  PMID: 27174199 BACKGROUND

• 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.

  PMID: 30224340 RESULT

Related Links

• Pediatric Molecular Imaging Program

MeSH Terms

Conditions

Osteonecrosis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Heike Daldrup-Link, MD
• Organization: Stanford University

mairead@stanford.edu

(650) 725-2548

Study Officials

• Heike Daldrup-Link, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology

Study Record Dates

• First Submitted: July 27, 2016
• First Posted: September 8, 2016
• Study Start: May 1, 2015
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: November 26, 2024
• Results First Posted: November 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)