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

May 19, 2016 updated by: Scott Potenta, MD, PhD
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ferumoxytol-enhanced MRI
This is a single-arm study. All enrolled patients will have a ferumoxytol-enhanced MRI scan.
Drug: Ferumoxytol
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.
Other Names:
  • Feraheme
Other: Magnetic Resonance Imaging
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.
Other Names:
  • MRI

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scott Potenta, MD, PhD

Investigators

  • Principal Investigator: Scott E Potenta, MD, PhD, University of Vermont Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

November 5, 2013

First Submitted That Met QC Criteria

November 12, 2013

First Posted (Estimate)

November 14, 2013

Study Record Updates

Last Update Posted (Estimate)

May 20, 2016

Last Update Submitted That Met QC Criteria

May 19, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRMS 14-096

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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