Ferumoxytol-enhanced Magnetic Resonance Imaging

NCT ID: NCT06348524

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2022-12-30

Brief Summary

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.

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Single arm utilizing ferumoxytol

Group Type: EXPERIMENTAL

Ferumoxytol injection

Intervention Type: DRUG

ferumoxytol will assess patency of coronary arteries

Interventions

Ferumoxytol injection

ferumoxytol will assess patency of coronary arteries

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Hypersensitivity to intravenous iron products

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Transmed Solutions

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew M Siedlecki, MD

Role: PRINCIPAL_INVESTIGATOR

authorized representative

Other Identifiers

ferumoxytol_2015

Identifier Type: -

Identifier Source: org_study_id