Ferumoxytol-enhanced Magnetic Resonance Imaging

There are no current alternatives to diagnostic contrast-requiring imaging for patients with an eGFR <30mL/min due to the association of gadolinium-based imaging modalities to nephrogenic systemic fibrosis and iodinated contrast-induced kidney injury. Ferumoxytol-enhanced imaging may offer an alternative approach.

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Ferumoxytol injection

Detailed Description

This is a case control study which will assess the resolution by which the coronary arteries can be visualized using ferumoxytol-enhanced cardiac magnetic resonance angiography (fcMRA) in patients with prior regional cardiac ischemia localized by stress-induced echocardiography. Resolution will be compared to invasive coronary arteriography completed in all patients that will be analyzed at the end of the study.

Masked experts will interpret fcMRA images to determine if coronary stenosis is present or absent. By strict definitions, this is a single-arm study. However comparison will be made between fcMRA and invasive coronary arteriography performed in each patient. With a prevalence of disease of approximately 0.35 in the study population, it is anticipated that both sensitivity and specificity of fcMRA to identify the absence of coronary artery stenosis can be calculated.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 3

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Both female and male participants are being studied aged 18-85 years old with an estimated glomerular filtration rate (eGFR) of less than 30ml/min/1.73 meters squared. Patients will have undergone cardiac screening tests that warrant further evaluation. Patients will be excluded with an eGFR >30ml/min/1.73 meters squared.

Inclusion criteria:

Diagnosis of chronic kidney disease Diagnosis of anemia of chronic kidney disease

Exclusion criteria:

Hypersensitivity to intravenous iron products

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm utilizing ferumoxytol	Drug: Ferumoxytol injection; ferumoxytol will assess patency of coronary arteries

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detect the absence of ≥50% stenosis in the coronary artery tree	This outcome derives from the central hypothesis which states that coronary artery disease can more effectively be excluded in patients with severe chronic kidney disease using ferumoxtyol enhanced cardiac magnetic resonance angiography (fcMRA) rather than non-invasive cardiac testing combined with ICA. The presence or absence of a single 50% stenosis in the region of interest (measured as described above) will be dichotomized (0=absent/ 1= present) from each of the two measures, fcMRA and invasive coronary arteriography	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detect stenosis in proximal and distal segments of the coronary artery tree	The purpose of this secondary outcome is to determine the sensitivity and specificity of fcMRA to detect the absence of lesions exhibiting ≥50% stenosis compared to ICA in proximal and distal arterial segments	12 months
Compare ferumoxtyol enhanced magnetic resonance angiography with stress echocardiography	The purpose of this secondary outcome is to determine the sensitivity and specificity of fcMRA to dobutamine stress echocardgiography testing in the assessment of coronary artery stenosis when compared to ICA.	12 months

Collaborators and Investigators

• Sponsor: Transmed Solutions
• Investigators: Principal Investigator: Andrew M Siedlecki, MD, authorized representative

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: July 29, 2023
• First Submitted That Met QC Criteria: March 31, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: August 1, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease; Hematinics; Pharmaceutical Solutions; Parenteral Nutrition Solutions; Ferrosoferric Oxide
• Other Study ID Numbers: ferumoxytol_2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No