Diagnostic Accuracy of Ferumoxytol-Enhanced MRI for Detecting Lymph Node Metastases in Colorectal Cancer

Not Applicable

Withdrawn

• Conditions: Colorectal Cancer
• Interventions: Drug: Ferumoxytol; Other: Magnetic Resonance Imaging

• Registration Number: NCT01983371
• Lead Sponsor: Scott Potenta, MD, PhD

Brief Summary

The purpose of this study is to determine the diagnostic accuracy of ferumoxytol-enhanced MRI in detecting lymph nodes that have been invaded by tumor cells in patients with colorectal cancer.

Detailed Description

This study will investigate the accuracy of ferumoxytol-enhanced MRI in detecting lymph nodes that have been invaded by tumor cells in patients with colorectal cancer. This study will be performed in addition to any ongoing routine care and will not serve as a substitute for any imaging tests that would be routinely performed prior to surgery.

Study Timeline

• Study First Submitted: 2013-11-05
• Study First Submitted QC: 2013-11-12
• Study First Posted: 2013-11-14
• Study Start: 2013-12
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-19
• Last Update Posted: 2016-05-20
• Primary Completion: 2016-06
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients 18 years of age or older with histologically confirmed colorectal cancer
• Planned for surgical resection of tumor

Exclusion Criteria

• Contraindications for MRI
• Contraindication or known allergy to ferumoxytol or parental iron products (e.g. iron sucrose, iron dextran, etc.)
• Planned chemotherapy or radiation treatment prior to surgical resection of primary tumor
• Uncontrolled serious medical illness
• Unable or unwilling to give informed consent
• Pregnancy
• Breastfeeding women
• Clinically documented or known risk of primary or secondary iron overloading including history of thalassemia, sickle cell anemia, hereditary hemochromatosis or first-degree relative with known hemochromatosis, multiple transfusions for any reason within the past 5 years, or use of over-the-counter ferrous sulfate without the supervision of his/her doctor

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ferumoxytol-enhanced MRI	Magnetic Resonance Imaging	This is a single-arm study. All enrolled patients will have a ferumoxytol-enhanced MRI scan.
Ferumoxytol-enhanced MRI	Ferumoxytol	This is a single-arm study. All enrolled patients will have a ferumoxytol-enhanced MRI scan.

Primary Outcome Measures

Name	Time	Method
Prospectively evaluate the diagnostic accuracy of ferumoxytol-enhanced MRI in the setting of colorectal cancer with histopathologic analysis as the gold standard.	3 years

Trial Locations

Locations (1)

University of Vermont Medical Center; 🇺🇸 Burlington, Vermont, United States