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临床试验/NCT03711890
NCT03711890暂停不适用

Imaging and Detection of Micrometer Sized Early Stage Pancreatic Cancer by Using Endoscopic Ultra-High Resolution Optical Coherence Tomography (OCT) Using Resected Pancreatic Specimen, a Pilot Study

Ohio State University Comprehensive Cancer Center2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2019年3月26日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
入组人数
75
试验地点
2
主要终点
Measure accuracy of using OCT to diagnose pancreatic cancer and compare with histology.

研究概览

简要总结

This trial studies how well ultra-high resolution optical coherence tomography works in detecting micrometer sized early stage pancreatic cancer in participants with pancreatic cancer. Ultra-high resolution optical coherence tomography may help to accurately identify pancreatic cancer in resected pancreatic specimens.

详细描述

PRIMARY OBJECTIVES:

I. To evaluate the using of optical coherence tomography (OCT) to diagnose pancreatic cancer arising in the setting of intraductal papillary mucinous neoplasms (IPMN) using the resected pancreatic specimen.

II. To correlate OCT imaging diagnosis with histologic findings in the human pancreatic duct.

IPMN is a premalignant lesions arising in the pancreas. Typically, IPMNs are identified incidentally on imaging performed for other reason or related to vague abdominal pain or gastrointestinal complaints. In terms of IPMN, invasive cancer can be found in this setting between 20 to 50% of the time[7] Therefore, if a patient is diagnosed with IPMN, especially main duct type, the general recommendation is to undergo resection. We propose to assess the duct of the pancreatic specimen after resection to identify evidence of invasive malignancy by OCT imaging. Afterwards, the specimen will be undergoing histopathologic assessment using standard protocols. Our hypothesis is that OCT will accurately identify pancreatic cancer in resected pancreatic specimen. The assessment with OCT is non-invasive and will not harm to change the specimen prior to going to pathology for standard review. Future studies will then focus on using this imaging technique in vivo to endoscopically identify early stage pancreatic cancer.

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

入选标准

  • Immediate surgery cohort: Adult patients with pancreatic cancer or IPMN
  • Immediate surgery cohort: Informed consent will be obtained
  • Adult patients undergoing pancreatic resection for a presumed IPMN

排除标准

  • 未提供

结局指标

主要结局

Measure accuracy of using OCT to diagnose pancreatic cancer and compare with histology.

时间窗: Up to 3 years

Will evaluate the accuracy of the optical coherence tomography (OCT) based diagnosis compare to the pathological diagnosis or the cancer cell derived exosomes test from the blood sample. Will compare the diagnosis results from the OCT imaging technology to standard histopathologic assessment and the blood test using 2-way tables. The agreement between two tests will be summarized with the overall agreement and the Cohen?s Kappa values.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mary Dillhoff

Principal Investigator

Ohio State University Comprehensive Cancer Center

研究点 (2)

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