Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2026-03-09 @ 2:27 AM
Study NCT ID:
NCT02857218
Status:
WITHDRAWN
Last Update Posted:
2021-09-16
First Post:
2016-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ferumoxytol-Enhanced MRI in Imaging Lymph Nodes in Patients With Stage IIB-IIIC Esophageal Cancer
Sponsor:
OHSU Knight Cancer Institute
Organization:
Study Overview
Official Title:
A Pilot Study Using a Novel Imaging of Lymph Nodes in Patients With Locally Advanced Esophageal Cancer Using Ferumoxytol Enhanced MRI
Status:
WITHDRAWN
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Inadequate enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This pilot clinical trial studies how well ferumoxytol-enhanced magnetic resonance imaging (MRI) works in imaging lymph nodes in patients with stage IIB-IIIC esophageal cancer. Ferumoxytol is a form of very small iron particles that are taken up by cells in normal lymph nodes and may work better in imaging patients with esophageal cancer when paired with MRI.
Detailed Description:
PRIMARY OBJECTIVE:
I. To determine feasibility of administering ferumoxytol and obtaining ferumoxytol enhanced magnetic resonance (MR) images in patients with resectable locally advanced esophageal cancer before starting neoadjuvant chemoradiation therapy and again before esophagectomy.
SECONDARY OBJECTIVES:
I. To collect detailed information about the location of ultrasmall superparamagnetic iron oxide (USPIO)-MRI detected lymph nodes prior to neoadjuvant chemoradiation therapy and again prior to esophagectomy.
II. To determine the sensitivity and specificity of ferumoxytol enhanced MR imaging in the assessment of pathologic lymph node involvement based on pathological findings at the time of esophagectomy.
OUTLINE:
Patients receive ferumoxytol intravenously (IV) over 15 minutes and then undergo ferumoxytol-enhanced MRI after 24-36 hours and before surgery at week 12.
After completion of study treatment, patients are followed up for 4-6 weeks.
I. To determine feasibility of administering ferumoxytol and obtaining ferumoxytol enhanced magnetic resonance (MR) images in patients with resectable locally advanced esophageal cancer before starting neoadjuvant chemoradiation therapy and again before esophagectomy.
SECONDARY OBJECTIVES:
I. To collect detailed information about the location of ultrasmall superparamagnetic iron oxide (USPIO)-MRI detected lymph nodes prior to neoadjuvant chemoradiation therapy and again prior to esophagectomy.
II. To determine the sensitivity and specificity of ferumoxytol enhanced MR imaging in the assessment of pathologic lymph node involvement based on pathological findings at the time of esophagectomy.
OUTLINE:
Patients receive ferumoxytol intravenously (IV) over 15 minutes and then undergo ferumoxytol-enhanced MRI after 24-36 hours and before surgery at week 12.
After completion of study treatment, patients are followed up for 4-6 weeks.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: