Ferumoxytol as a Contrast Agent for Pulmonary Magnetic Resonance Angiography

NCT03173066 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 0430172034
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

• Pulmonary embolus

  Detection of pulmonary embolus with ferumoxytol-enhanced magnetic resonance angiography

  1 year

Study Arms (1)

Single Arm

EXPERIMENTAL

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

Interventions

Ferumoxytol DRUG

ferumoxytol-enhanced magnetic resonance angiography for the diagnosis of pulmonary embolus

Also known as: Feraheme

Single Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• 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.

  PMID: 26786296 RESULT

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Ferrosoferric Oxide

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals

Study Officials

• Andrew M Siedlecki, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Medicine

Model Details: single-arm, open label

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 1, 2017
• Study Start: September 21, 2018
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)