Improved Pre-Operative Staging of Pancreatic Cancer Using Superparamagnetic Iron Oxide Magnetic Resonance Imaging (SPIO MRI)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- To Determine the Sensitivity High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles to Identify Small and Otherwise Undetectable Lymph Node Metastases.
研究概览
简要总结
The purpose of this research study is to see if a specific kind of MRI, called Ultrasmall Superparamagnetic Iron Oxide Magnetic Resonance Imaging (USPIO MRI), which uses an FDA-approved therapeutic agent(Feraheme) to see if it is able to identify small and otherwise undetectable lymph node metastases in people who have pancreatic cancer and are scheduled for surgical resection.
详细描述
- On the first day, study participants will undergo 2 MRI examinations. A scan will be done prior to administration of the contrast agent (Feraheme) and then a second scan immediately after administration. On the second day, study participants will be asked to return for a third MRI.
- All MRI scans will be done at Massachusetts General Hospital.
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
- •Locally resectable pancreatic mass present on one or more pre-operative imaging modalities
- •Must demonstrate no evidence of distant metastases as assessed by chest/abdomen/pelvis CT scan
- •Deemed eligible for resection with curative intent by a treating surgeon who is listed as an investigator on this study
- •18 years of age or older
- •No uncontrolled serious medical or psychiatric illness
- •Women of childbearing potential must not be pregnant or lactating
排除标准
- •Known allergy to iron or dextran
- •Pregnant or lactating
- •Counter-indication to MRI, such as the presence of metallic prostheses or implanted metal device
- •Sickle cell disease or hemoglobinopathy
研究组 & 干预措施
SPIO MRI
干预措施: Superparamagnetic Iron Oxide Magnetic Resonance Imaging (Drug)
结局指标
主要结局
To Determine the Sensitivity High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles to Identify Small and Otherwise Undetectable Lymph Node Metastases.
时间窗: 3 years
Using Pathology as the gold standard the excised nodes were correlated and the percentage of positive cases were measured on the post contrast exam. Sensitivity is the percentage of positive cases (i.e., metastases confirmed using pathology) identified as positive.
To Determine the Specificity of High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles to Identify Small and Otherwise Undetectable Lymph Node Metastases.
时间窗: 3 years
Using Pathology as the gold standard the excised nodes were correlated and the percentage of true negative nodes were measured on the post contrast exam. Specificity is the percentage of true negative cases as identified as negative.
次要结局
未报告次要终点
研究者
Ralph Weissleder, MD
Professor of Radiology
Massachusetts General Hospital