MRI With Secretin Enhancement to Increase Conspicuity of Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Difference in lesion conspicuity between S-MRI and N-MRI
研究概览
简要总结
The aim of the study is to evaluate the utility of secretin-enhanced MRI (S-MRI) in detecting and measuring pancreatic lesions in patients with known adenocarcinoma or Intraductal papillary mucinous neoplasm (IPMN) lesions. The hypothesis is that S-MRI is superior to MRI without secretin enhancement (N-MRI) in increasing tumor conspicuity, allowing for improved identification and more accurate measurement of lesions or precursor lesions in the pancreas.
详细描述
Pancreatic cancer remains the fourth leading cause of cancer-related death in the United States and is marked by advanced stage at diagnosis and a high mortality rate. Intraductal papillary mucinous neoplasm (IPMN) is a cystic lesion that can be potentially cancerous, leading to pancreatic adenocarcinoma. Currently, there is no existing imaging modality that is both sensitive and cost-effective enough in accurately measuring or detecting adenocarcinoma and IPMN. Improving the methods used in identification and localization of this disease is critical.
Secretin, a hormone produced by duodenal mucosal cells increases blood-flow to the pancreas. The investigators' hypothesis is that as secretin increases blood flow to the pancreas, there will be increased conspicuity in areas of dysplasia/cancer where there is minimal blood-flow, enhancing tumor detection. The investigators are conducting a prospective, randomized-control pilot study of thirty subjects with IPMN or pancreatic cancer who are undergoing surgical resection at Columbia University's Pancreas Center. Fifteen subjects will be randomly selected to undergo S-MRI prior to surgery and fifteen subjects will be selected as controls, undergoing MRI without secretin-enhancement and matched for age, sex, race and tumor-type. The investigators will first evaluate if secretin allows for increased tumor conspicuity, enhanced visualization of the lesion, by comparing the calculated tumor conspicuity of S-MRI to N-MRI groups.
The investigators will then assess if S-MRI imaging allows for increased accuracy in lesion measurements by looking at the concordance in measurements between S-MRI and tumor specimens post-resection as compared to the concordance in measurements between N-MRI and tumor specimens post-resection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Histologically confirmed IPMN/pancreatic adenocarcinoma by biopsy or fine needle or suspected IPMN/pancreatic adenocarcinoma based on imaging
- •Scheduled for surgical resection
- •Willingness to provide informed consent.
排除标准
- •Any contraindication to magnetic resonance imaging (MRI), including but not limited to implanted metal devices (e.g. pacemaker, berry aneurysm clips, neural stimulator or cochlear implants)
- •Unresectable tumor
- •Other abdominal neoplasm in addition to neoplasm in pancreas
- •Contraindication to surgery, including but not limited to recent myocardial infarction (MI) (within 6 weeks) or poor pulmonary function
- •History of sensitivity to secretin
- •Pregnancy
- •Estimated glomerular filtration rate (GFR) < 30 mL/min/1.73 m2 (as per Modification of Diet in Renal Disease (MDRD) Study equation)
- •Unwillingness or inability to provide informed consent.
研究组 & 干预措施
Experimental
Fifteen subjects will be randomly selected to undergo S-MRI prior to surgery. These subjects would receive Secretin, administered by IV bolus injection over 1 minute followed by a 30 second saline flush.
干预措施: Secretin (Drug)
结局指标
主要结局
Difference in lesion conspicuity between S-MRI and N-MRI
时间窗: 30 days
The primary outcome is whether S-MRI allows for better tumor detection secondary to anticipated increased conspicuity of tumor due to secretin's effect on increasing blood flow to the normal pancreas as compared to N-MRI. Determining S-MRI's efficacy versus that of N-MRI will be carried out by comparing tumor conspicuity measurements in S-MRI and N-MRI groups. Tumor conspicuity will be measured by calculating the contrast to noise ratio, placing region of interest (ROI) on tumor and adjacent tissue and dividing by image noise.
次要结局
- Concordance of tumor measurements between S-MRI images and tumor specimens post-resection vs. concordance of tumor measurements between N-MRI and tumor specimens post-resection(45 days)
研究者
Elizabeth Hecht
Associate Professor of Clinical Radiology
Columbia University