NCT00588367已完成不适用
CT Perfusion of Pancreatic Cancer and Chronic Pancreatitis: Feasibility Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- A reproducible technique to measure CT perfusion parameters may provide a method for non-invasively monitoring tumor response during treatment, or differentiating between autoimmune and chronic pancreatitis.
研究概览
简要总结
- Pancreatic CT perfusion with a biofeedback breathing belt worn by the participant, and using novel post-processing techniques, is a reliable method which can be used to differentiate between pancreatic cancer, chronic pancreatitis, and autoimmune pancreatitis.
- Pancreatic CT perfusion can be used to monitor patients undergoing decompression treatment (endoscopic retrograde cholangiopancreatography with stent placement) for painful chronic pancreatitis, and the change in the pancreatic perfusion parameters correlate with the change in the pain parameters (pain scale and analgesic use).
- Pancreatic CT perfusion parameters can be calculated using surrogate scan data sets at specific time points to replace the continuous scanning.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •a. Suspected pancreatic adenocarcinoma, age 35 to 99 years.
- •a. Chronic pancreatitis with chronic pain, age 18 to 99 years. Must be a confirmed diagnosis by either CT, endoscopic ultrasound (EUS), or endoscopic retrograde cholangiopancreatography (ERCP).
- •2b. To undergo endoscopic or surgical decompression with 0 to 10 days of first study visit CT perfusion scan.
- •2c. To answer pain questionnaire before first CT perfusion scan.
- •2d. To return within three weeks to three months after decompression treatment for another CT perfusion scan and complete the second pain questionnaire.
- •3a. Autoimmune pancreatitis, age 18 to 99 years either with diffuse or focal swelling of the pancreas confirmed by CT, MRI, or EUS or
- •3b. Irregular narrowing of the pancreatic duct on ERCP and either elevated serum immunoglobulin G4 (IgG4), or histological confirmation.
排除标准
- •1a. Pancreatic ductal adenocarcinoma tumors with vascular involvement but without vascular occlusion.
- •b. Pancreatic ductal adenocarcinoma tumors less than 2 cm in size.
- •a. Chronic pancreatitis with diffuse and extensive pancreatic calcification.
- •a. Autoimmune pancreatitis with a prior pancreas surgery or steroid treatment for autoimmune pancreatitis .
- •Any Cohort:
- •Prior iodine contrast reactions.
- •Iodine allergy.
- •Decreased kidney function being a serum creatinine greater than 1.5mg/dl.
- •Any contraindication to having a CT scan with iodine contrast.
结局指标
主要结局
A reproducible technique to measure CT perfusion parameters may provide a method for non-invasively monitoring tumor response during treatment, or differentiating between autoimmune and chronic pancreatitis.
时间窗: Three weeks to three months for chronic pancreatitis.
次要结局
未报告次要终点
研究者
Naoki Takahashi
Principal Investigator
Mayo Clinic
研究点 (1)
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