Overview
Diagnostic Accuracy of Ferumoxytol-Enhanced MRI for Detecting Lymph Node Metastases in Colorectal Cancer
Status:
Withdrawn
Withdrawn
Trial end date:
2016-06-01
2016-06-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Scott Potenta, MD, PhDTreatments:
Ferrosoferric Oxide
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