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



Status:Withdrawn
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:5/21/2016
Start Date:December 2013
End Date:June 2016

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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.

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.

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
We found this trial at
1
site
Burlington, Vermont 05405
Principal Investigator: Scott E Potenta, MD, PhD
Phone: 802-847-0000
?
mi
from
Burlington, VT
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