Ferumoxytol-enhanced Imaging of Osteomyelitis
Ferumoxytol Contrast for the MRI Imaging of Osteomyelitis
1 other identifier
interventional
12
1 country
1
Brief Summary
Diabetic foot infections contribute to 75,000 hospitalizations in the US each year. There is a lifetime incidence of 15-25% of foot infections in diabetics. The investigators hypothesize that ferumoxytol (FDA approved for use in CKD patients, unlike gadolinium) will improve the accuracy of MR imaging in the diagnosis of osteomyelitis by allowing for the specific imaging of macrophages that have taken up the iron-based compound. In this study the investigators will image 12 patients with suspected diabetic osteomyelitis using ferumoxytol-contrasted MRI, and evaluate the feasibility of this approach.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2014
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 12, 2014
CompletedFirst Submitted
Initial submission to the registry
June 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 12, 2019
CompletedFirst Posted
Study publicly available on registry
July 25, 2023
CompletedJuly 25, 2023
December 1, 2016
5.5 years
June 5, 2015
July 17, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
contrast changes
To measure the contrast changes of osteomyelitis on ferumoxytol-contrasted MRI.
6 weeks
Secondary Outcomes (4)
ferumoxytol-enhanced MRI
6 weeks
signal to noise ratio (SNR) difference and relative enhancement (RE)
6 weeks
positive anti-dextran coating
6 weeks
Worsening osteomyelitis infection
24 hours
Study Arms (1)
study group
EXPERIMENTALPatients will receive Ferumoxides 11.2Mg Solution for Injection.
Interventions
the drug will be injected at a single dose of up to 7 mg/Kg and MRI will be performed after 24 hrs.
Eligibility Criteria
You may qualify if:
- patients in which a diagnosis of pedal osteomyelitis is being entertained,
- years or older,
- a medical indication for an MRI and have diabetes.
You may not qualify if:
- patients that are septic and clinically unstable as determined by the primary medical teams.
- Patients with a contra-indication to MRI (metal in body, etc) or hemochromatosis will be excluded.
- Pregnant patients will be excluded.
- Patients unable to understand the consent form and prisoners will be excluded.
- Female patients with hct \>48% and males with hct\>52% will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of New Mexico
Albuquerque, New Mexico, 87131, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laurel Sillerud, PhD
UNM
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2015
First Posted
July 25, 2023
Study Start
February 12, 2014
Primary Completion
August 12, 2019
Study Completion
August 12, 2019
Last Updated
July 25, 2023
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will not share