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

Study Overview
=================
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.

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

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: Ferumoxytol
* Other: Magnetic Resonance Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ferumoxytol-enhanced MRI<br>This is a single-arm study. All enrolled patients will have a ferumoxytol-enhanced MRI scan. | Drug: Ferumoxytol<br>* All study patients will receive a dose of ferumoxytol for the MRI. Ferumoxytol will be administered intravenously at a dose of 6 mg/kg, for a maximum dose of 510 mg.<br>* Other names: Feraheme;Other: Magnetic Resonance Imaging<br>* All study patients will undergo a ferumoxytol-enhanced MRI in addition to any other ongoing care for colorectal cancer. Histopathologic analysis of lymph nodes will be the gold standard for determining lymph node status.<br>* Other names: MRI;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prospectively evaluate the diagnostic accuracy of ferumoxytol-enhanced MRI in the setting of colorectal cancer with histopathologic analysis as the gold standard. |  | 3 years |