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Imaging of Osteonecrosis With Ferumoxytol-Enhanced MRI (Osteonecro)

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ClinicalTrials.gov Identifier: NCT02893293
Recruitment Status : Enrolling by invitation
First Posted : September 8, 2016
Last Update Posted : August 25, 2022
Sponsor:
Information provided by (Responsible Party):
Heike E Daldrup-Link, Stanford University

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

Condition or disease Intervention/treatment Phase
Osteonecrosis Drug: Ferumoxytol-enhanced magnetic resonance imaging Device: Magentic Resonance Imaging Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Imaging of Osteonecrosis With Ferumoxytol-Enhanced MRI
Actual Study Start Date : May 2015
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Ferumoxytol

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 Name: 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 Name: MRI




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02893293


Locations
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United States, California
Lucile Packard Children's Hospital
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Heike Daldrup-Link, MD, PhD Stanford University
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Heike E Daldrup-Link, Professor of Radiology, Stanford University
ClinicalTrials.gov Identifier: NCT02893293    
Other Study ID Numbers: IRB-20253(osteonecrosis)
PEDSBONE0006 ( Other Identifier: OnCore )
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: August 25, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteonecrosis
Bone Diseases
Musculoskeletal Diseases
Necrosis
Pathologic Processes
Ferrosoferric Oxide
Hematinics
Parenteral Nutrition Solutions
Pharmaceutical Solutions