Diagnostic Accuracy of Ferumoxytol-Enhanced MRI for Detecting Lymph Node Metastases in Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Prospectively evaluate the diagnostic accuracy of ferumoxytol-enhanced MRI in the setting of colorectal cancer with histopathologic analysis as the gold standard.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years of age or older with histologically confirmed colorectal cancer
- •Planned for surgical resection of tumor
排除标准
- •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
研究组 & 干预措施
Ferumoxytol-enhanced MRI
This is a single-arm study. All enrolled patients will have a ferumoxytol-enhanced MRI scan.
干预措施: Ferumoxytol (Drug)
Ferumoxytol-enhanced MRI
This is a single-arm study. All enrolled patients will have a ferumoxytol-enhanced MRI scan.
干预措施: Magnetic Resonance Imaging (Other)
结局指标
主要结局
Prospectively evaluate the diagnostic accuracy of ferumoxytol-enhanced MRI in the setting of colorectal cancer with histopathologic analysis as the gold standard.
时间窗: 3 years
次要结局
未报告次要终点
研究者
Scott Potenta, MD, PhD
Clinical Instructor
University of Vermont