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

Sponsor
Scott Potenta, MD, PhD (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01983371
Collaborator
(none)
0
Enrollment
1
Location
1
Arm
30
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Diagnostic Accuracy of Ferumoxytol-Enhanced MRI for Detecting Lymph Node Metastases in Colorectal Cancer
Study Start Date :
Dec 1, 2013
Anticipated Primary Completion Date :
Jun 1, 2016
Anticipated Study Completion Date :
Jun 1, 2016

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Prospectively evaluate the diagnostic accuracy of ferumoxytol-enhanced MRI in the setting of colorectal cancer with histopathologic analysis as the gold standard. [3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Vermont Medical Center Burlington Vermont United States 05401

    Sponsors and Collaborators

    • Scott Potenta, MD, PhD

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Scott Potenta, MD, PhD, Clinical Instructor, University of Vermont
    ClinicalTrials.gov Identifier:
    NCT01983371
    Other Study ID Numbers:
    • CHRMS 14-096
    First Posted:
    Nov 14, 2013
    Last Update Posted:
    May 20, 2016
    Last Verified:
    May 1, 2016
    Additional relevant MeSH terms:
    Colorectal Neoplasms
    Lymphatic Metastasis
    Ferrosoferric Oxide

    Study Results

    No Results Posted as of May 20, 2016