Optical Frequency Domain Imaging (OFDI) Surveillance and Image Guided Biopsy of the Esophagus
Pilot Study to Evaluate OFDI Surveillance and Image Guided Biopsy of the Esophagus
研究概览
详细说明
Twenty four consenting patients undergoing esophagogastroduodenoscopy (EGD) surveillance following a confirmed diagnosis of Barrett's esophagus will be recruited at Massachusetts General Hospital (MGH) . Along with Optical Frequency Domain Imaging (OFDI) imaging and cautery marking for targeted biopsy, the patients will undergo a standard of care clinical Esophagogastroduodenoscopy (EGD) procedure including endoscopic random biopsy. This study requires the use of a balloon catheter which is a commonly used technique and is accepted in clinical practice for dilation of esophageal and colonic strictures and for photodynamic therapy.
Once in position, the OFDI tissue marking laser will be activated by the physician. The physician will control the marking and make two marks of a duration of 2 seconds each. The 2 seconds time period will limit the tissue effects to only the superficial layers of the esophageal mucosa.
It is expected that the total experimental time including insertion and inflation of the OFDI balloon catheter, OFDI imaging, tissue marking, and removal of the OFDI balloon will add approximately 15 minutes to the total length of the EGD.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02114
- Massachusetts General Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients undergoing an EGD for Barrett's esophagus surveillance with a prior confirmed Barrett's segment at least 1 cm in length
- Patients must be over the age of 18
- Patient must be able to give informed consent
- Women with child bearing potential must have a negative pregnancy test prior to procedure
Exclusion Criteria:
- Patients on anti-platelet and anti-coagulation medications and NSAIDS at the time of procedure
- Patients with a history of hemostasis disorders
- Patients that are pregnant
- Patients with esophageal strictures
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:MGH OFDI marking and imaging
OFDI imaging
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Imaging of esophagus with OFDI system
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Number of Subjects in Which the Targeted Locations Identified Through OFDI Imaging Correlates With the Biopsies.
大体时间:day 1, during diagnostic procedure
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Determination of the feasibility to mark targeted pathologic locations identified through OFDI imaging using superficial cautery marks.Verification by endoscopy and utilization of the marks for biopsy guidance.Images will be analyzed and compared to biopsies of the correlated marked tissue.
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day 1, during diagnostic procedure
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合作者和调查者
调查人员
- 首席研究员:Guillermo Tearney, MD PhD、Massachusetts General Hospital
- 首席研究员:Norman Nishioka, MD、Massachusetts General Hospital
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
MGH OFDI marking的临床试验
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Massachusetts General HospitalNational Cancer Institute (NCI); National Institutes of Health (NIH)完全的
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Massachusetts General HospitalNational Cancer Institute (NCI); National Institutes of Health (NIH)主动,不招人
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Massachusetts General HospitalNational Cancer Institute (NCI); National Institutes of Health (NIH)主动,不招人
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Massachusetts General HospitalNational Cancer Institute (NCI)完全的
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Massachusetts General HospitalNational Cancer Institute (NCI); Mayo Clinic; Columbia University; National Institutes of Health... 和其他合作者主动,不招人