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Esophageal Neoplasms

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Iron

Ferrosoferric Oxide

Parenteral Nutrition Solutions

Patients will undergo a pre-contrast MRI followed by a pre determined dose of of IV Ferumoxyto. Post-contrast MRI imaging will be performed immediately following Ferumoxytol infusion and 48 hours after Ferumoxytol administration with subsequent image analysis.

Ferumoxytol

MRI 3T scanner

Yolonda Colson, MD PhD

This research study is evaluating a new imaging method using MRI (magnetic resonance imaging) to evaluate lymph nodes for evidence of tumor spread from esophageal cancer. This MRI study involves an intravenous contrast called Ferumoxytol (FerahemeTM).

This research study is a Pilot clinical trial, which is the first time investigators are examining this study intervention.

This study tests the safety of the investigational intervention (MRI imaging with Ferumoxytol) and assesses the feasibility of identifying malignant lymph nodes (lymph nodes that have tumor in them) by comparing the experimental MRI findings with the final pathology report from surgery.

This iron-based agent currently has approval from the U.S. Food and Drug Administration (FDA) for use in iron replacement therapy, however, its use in MRI imaging is not FDA-approved and is thus experimental in this trial.

MRI Iron Oxide Imaging for Lymph Node Staging in Esophageal Cancer

Feasibility is determined by the ability of the radiologist to identify esophageal associated lymph nodes and which ones may be metastatic based on the uptake of ferumoxytol. Positive nodes are identified by the radiologist based on altered signal in those with ferumoxytol uptake compared to the signal normal lymph nodes on MRI

Safety is determined by none of the 10 patients developing a grade 3 or 4 reaction as per the Common Toxicity Criteria scale (NCI-CTCAE version 4.0)

Accuracy is determined by the positive metastatic nodes identified on MRI as compared to those found on pathologic examination

AMAG Pharmaceuticals, Inc.

Dana-Farber Cancer Institute

Yolonda Colson MD PhD

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
MRI Iron Oxide Imaging for Lymph Node Staging in Esophageal Cancer	NCT02689401	Esophageal Canc...	Ferumoxytol MRI 3T scanner	18 Years -	Dana-Farber Cancer Institute
MRI Iron Oxide Imaging for Lymph Node Staging in Esophageal Cancer	NCT02689401	Esophageal Canc...	Ferumoxytol MRI 3T scanner	18 Years -	Dana-Farber Cancer Institute
MRI Iron Oxide Imaging for Lymph Node Staging in Esophageal Cancer	NCT02689401	Esophageal Canc...	Ferumoxytol MRI 3T scanner	18 Years -	Dana-Farber Cancer Institute

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