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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Determine the feasibility of using MRI-ferumoxytol for the identification of metastatic lymph nodes in patients with 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
Time frame: 2 years
Assess the safety of intravenous ferumoxytol for the use in esophageal cancer patients
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)
Time frame: 2 years
Determine the accuracy of MRI-ferumoxytol for the identification of positive metastatic nodes in patients with esophageal cancer
Accuracy is determined by the positive metastatic nodes identified on MRI as compared to those found on pathologic examination
Time frame: 2 years
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