NCT02689401

MRI Iron Oxide Imaging for Lymph Node Staging in Esophageal Cancer

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	Ferumoxytol
DEVICE	MRI 3T scanner

Timeline

• Start date: 2016-05-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2016-02-24
• Last updated: 2016-05-13