Clinical trial

Ferumoxytol Contrast for the MRI Imaging of Osteomyelitis

Name

13-621

Description

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 arms

Trial start

2014-02-12

Estimated PCD

2019-08-12

Trial end

2019-08-12

Status

Completed

Phase

Early phase I

Treatment

Ferumoxides 11.2Mg Solution for Injection

the drug will be injected at a single dose of up to 7 mg/Kg and MRI will be performed after 24 hrs.

Arms:

study group

Other names:

Ferraheme

Size

Primary endpoint

contrast changes

6 weeks

Eligibility criteria

Inclusion criteria: * patients in which a diagnosis of pedal osteomyelitis is being entertained, * 18 years or older, * a medical indication for an MRI and have diabetes. Exclusion criteria: * 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 12, 'type': 'ACTUAL'}}

Updated at

2023-07-25

1 organization

1 product

1 indication

Organization

University of New Mexico

Product

Ferumoxides

Indication

Osteomyelitis