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Ferumoxytol as a Contrast Agent for Pulmonary Magnetic Resonance Angiography

Primary Purpose

Pulmonary Embolism

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ferumoxytol
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Embolism

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Pulmonary embolus
Detection of pulmonary embolus with ferumoxytol-enhanced magnetic resonance angiography

Secondary Outcome Measures

Full Information

First Posted
May 30, 2017
Last Updated
July 25, 2022
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03173066
Brief Title
Ferumoxytol as a Contrast Agent for Pulmonary Magnetic Resonance Angiography
Official Title
Ferumoxytol as a Contrast Agent for Pulmonary Magnetic Resonance Angiography
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
September 21, 2018 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
single-arm, open label
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ferumoxytol
Other Intervention Name(s)
Feraheme
Intervention Description
ferumoxytol-enhanced magnetic resonance angiography for the diagnosis of pulmonary embolus
Primary Outcome Measure Information:
Title
Pulmonary embolus
Description
Detection of pulmonary embolus with ferumoxytol-enhanced magnetic resonance angiography
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew M Siedlecki, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be offered in publication supplemental material
Citations:
PubMed Identifier
26786296
Citation
Mukundan S, Steigner ML, Hsiao LL, Malek SK, Tullius SG, Chin MS, Siedlecki AM. Ferumoxytol-Enhanced Magnetic Resonance Imaging in Late-Stage CKD. Am J Kidney Dis. 2016 Jun;67(6):984-8. doi: 10.1053/j.ajkd.2015.12.017. Epub 2016 Jan 16.
Results Reference
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Ferumoxytol as a Contrast Agent for Pulmonary Magnetic Resonance Angiography

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