Ferumoxytol as a Contrast Agent for Pulmonary Magnetic Resonance Angiography

Study Overview
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Brief Summary
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This proposal is based on findings from our previous work involving ferumoxytol-enhanced cardiac magnetic resonance angiography. The resolution of the pulmonary vasculature based on our previous imaging protocol was exceptional (PMID: 26786296). In the Partners Healthcare System between January 1, 2014 and January 1, 2015 there were 541 patients evaluated in Partners Healthcare-affiliated hospitals with a diagnosis of pulmonary embolism and acute or chronic kidney disease at the same visit between 01/01/2014 and 01/01/2015. Ventilation perfusion scanning was performed in 201 patients during this same time interval. Up to 63% of these patients in one year did not receive the diagnostic test of choice.

Detailed Description
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Thromboembolic events in patients with chronic kidney disease are out of proportion to age matched controls occurring 2.34 times more frequently than in non-CKD patients (PMID 19561505). At the same time, patients with kidney disease are not offered the gold standard for pulmonary embolus diagnosis, i.e. CT angiography, for concern of acute dialysis to treat contrast-induced nephropathy. Ventilation perfusion scintigraphy (V/Q) is the preferred diagnostic test for patients with advanced CKD (glomerular filtration rate <30mL/min/m2) and suspicion of pulmonary embolus, but can not be utilized if pulmonary parenchyma contains interstitial edema or alveolar occlusion due to pneumonia. If diagnostic tools for pulmonary embolus are not available, patients are subject to the risk of empiric treatment to avoid life-threatening complications of untreated pulmonary embolus. For those patients with CKD that undergo CT angiography, they are placed at risk of initiating dialysis. If this occurs multiple financial costs are associated with dialysis catheter placement and acute hemodialysis. If a patient instead is evaluated with gadolinium-based contrast modalities, there is the risk of nephrogenic systemic fibrosis and the morbidity associated with this iatrogenic disease process. Ferumoxytol-enhanced MRI could avoid the risk of iodinated contrast and gadolinium contrast and accelerate the diagnosis and treatment of patients with pulmonary embolus.

Official Title
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Ferumoxytol as a Contrast Agent for Pulmonary Magnetic Resonance Angiography

Conditions
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Pulmonary Embolism

Intervention / Treatment
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* Drug: Ferumoxytol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a clinical suspicion for pulmonary embolus estimated glomerular filtration rate (eGFR) <30mL/min/1.73m2 have been clinically disqualified from the use of iodine-based contrast studies, gadolinium-based contrast studies or nuclear-based detection studies Exclusion Criteria: received ferumoxytol in the previous six months anaphylactic reaction to other intravenous iron formulations calculated estimated glomerular filtration rate is >50mL/min/1.78m2 patients on dialysis with no residual renal function pregnant women and nursing mothers. Standard screening will be used by patients >65 years of age with BMI >45, and/or liver disease (Child-Pugh class C)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: single-arm, open label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>Patients with a clinical concern for pulmonary embolus but not able to receive iodinated contrast will be enrolled. Ferumoxytol will be administered as a contrast agent in coordination with magnetic resonance angiography to identify patency of the cardiopulmonary vasculature. | Drug: Ferumoxytol<br>* ferumoxytol-enhanced magnetic resonance angiography for the diagnosis of pulmonary embolus<br>* Other names: Feraheme;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary embolus | Detection of pulmonary embolus with ferumoxytol-enhanced magnetic resonance angiography | 1 year |