Pilot Study Using Secretin and Iodinated Intravenous Contrast and 64-Channel CT in Patients at High Risk for Pancreatic Adenocarcinoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Number of Subjects With Evidence of Pancreatic Tumor or Any Secondary Findings of Pancreatic Tumor as Shown by CT.
研究概览
简要总结
The purpose of this study is to test if secretin-enhanced CT is a useful noninvasive screening tool for pancreatic cancer in a high-risk population.
详细描述
Pancreatic cancer is the fourth most common cause of cancer death in the US. Because patients with pancreatic cancer rarely presents with disease specific symptoms until late in the course of the disease, identifying and developing surveillance strategies for early detection of asymptomatic pancreatic cancer is critical. EUS and fine needle aspirate (FNA) are currently the most accurate non-operative methods of establishing the presence or absence of pancreatic cancer.
The CT findings of pancreatic cancer include an attenuation difference between the pancreatic mass and the surrounding pancreatic parenchyma, pancreatic ductal dilation and cutoff, disruption of the normal fatty marbling of the pancreatic parenchyma, rounding of the inferior margin of the posterior head of the pancreas, atrophy of the proximal gland, and signs of locally advanced or distant disease. In a case-controlled retrospective review of pancreatic cancers missed at CT prior to clinical presentation at the Mayo Clinic, Gangi et al found that CT findings definite or suspicious for pancreatic cancer were present in 50% of scans obtained up to 18 months before the clinical diagnosis of pancreatic cancer. Pancreatic duct dilation and cutoff were early CT findings indicating tumor presence, and were associated with near-perfect and substantial interobserver agreement. Consequently, early pancreatic neoplasms likely result in at least partial occlusion of the duct, leading to subsequent ductal dilation.
We hypothesize that increased production of the pancreatic juice distends the otherwise small caliber pancreatic duct, and accentuate the secondary sign of pancreatic duct obstruction by a small pancreatic mass. The investigators will be able to take advantage of this physiologic effect of secretin, by obtaining multi-planar scans with isotropic resolution using a 64-channel CT system.
Secretin is a safe agent that increases pancreatic exocrine secretion. Intravenously administered secretin increases the pancreatic juice secretion, and magnetic resonance or CT scan obtained after secretin has been shown to improve visualization of the pancreatic duct.
Day 1: Patient will fast 4 hours prior to the study. 1 L of water is given by mouth as an oral contrast material 30 minutes prior to the study. After placing an angiocath in the antecubital fossa, the patient will be placed in a supine position on the CT scanner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons 50 years or older with recently diagnosed diabetes (within 2 years), with at least one of the following: no family history of diabetes, abdominal discomfort, anorexia, weight loss, elevated serum CA 19-9, or those undergoing EUS with or without Fine Needle Aspiration (FNA) for pancreatic cancer screening ; OR
- •Persons 35 years old or older with familial pancreatic cancer with 2 or more first degree relatives with pancreatic cancer; OR
- •Persons 35 years old or older with Peutz-Jeghers syndrome; OR
- •Persons 35 years old or older with suspicious clinical symptoms of pancreatic cancer, but had normal CT of the abdomen with iodinated contrast within 2 weeks.
排除标准
- •Persons with contraindication to iodinated contrast
- •Allergy to iodinated contrast
- •Renal insufficiency (serum creatinine > 1.5 mg/dl)
- •Patients with contraindication to ionizing radiation
- •Pregnancy
- •Patients with previous pancreatic surgery
- •Contraindication to secretin
- •Allergy to secretin
- •Acute pancreatitis
研究组 & 干预措施
New Onset Diabetes
Adults diagnosed diabetes within two years, and at least one of the following: no family history of diabetes, abdominal discomfort, anorexia, weight loss, elevated serum cancer antigen 19-9 (CA 19-9), or those undergoing endoscopic ultrasound (EUS) with or without Fine Needle Aspiration (FNA) for pancreatic cancer screening.
All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study.
干预措施: Synthetic Human Secretin (Drug)
Familial Pancreatic Cancer
Adults age 35-99 with familial pancreatic cancer with two or more first degree relatives with pancreatic cancer.
All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study.
干预措施: Synthetic Human Secretin (Drug)
Peutz-Jeghers Syndrome
Adults age 35-99 with Peutz-Jeghers syndrome.
All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study.
干预措施: Synthetic Human Secretin (Drug)
Clinical Symptoms of Pancreatic Cancer, Normal CT
Adults age 35-99 with suspicious clinical symptoms of pancreatic cancer, but had normal CT of the abdomen with iodinated contrast within 2 weeks.
All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study.
干预措施: Synthetic Human Secretin (Drug)
结局指标
主要结局
Number of Subjects With Evidence of Pancreatic Tumor or Any Secondary Findings of Pancreatic Tumor as Shown by CT.
时间窗: Day 1 of study
Subjects will receive the secretin test dose just prior to the CT scan. Definitions: Evidence of Pancreatic Tumor (low-attenuation mass), Secondary Findings of Pancreatic Tumor such as dilated pancreatic duct or liver masses suggestive of liver metastases.
次要结局
未报告次要终点
研究者
Naoki Takahashi
Associate Professor of Radiology,College of Medicine
Mayo Clinic
