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

Scott Potenta, MD, PhD

Status

Withdrawn

Conditions

Colorectal Cancer

Treatments

Drug: Ferumoxytol

Other: Magnetic Resonance Imaging

Study type

Interventional

Funder types

Other

Identifiers

NCT01983371

CHRMS 14-096

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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