- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03173066
Ferumoxytol as a Contrast Agent for Pulmonary Magnetic Resonance Angiography
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Single Arm
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.
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ferumoxytol-enhanced magnetic resonance angiography for the diagnosis of pulmonary embolus
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pulmonary embolus
Time Frame: 1 year
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Detection of pulmonary embolus with ferumoxytol-enhanced magnetic resonance angiography
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1 year
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0430172034
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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