MRI Iron Oxide Imaging for Lymph Node Staging in Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title: MRI Iron Oxide Imaging for Lymph Node Staging in Esophageal Cancer

Status Withdrawn

Clinical Trial Summary

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).

Clinical Trial Description

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

• NCT number: NCT02689401
• Study type: Interventional
• Source: Dana-Farber Cancer Institute
• Status: Withdrawn
• Phase: Phase 1
• Start date: May 2016
• Completion date: May 2016