The Diagnosis of NPC Using the Probe-based Confocal Laser Endomicroscopy
2018年1月31日 更新者：Huawei Li, Ph.D, MD、Eye & ENT Hospital of Fudan University
The Diagnosis of the Squamous Cell Carcinoma in Head and Neck by Using the Probe-based Confocal Laser Endomicroscopy
To evaluate the use of probe-based confocal laser endomicroscopy (pCLE) in human nasopharyngeal mucosa for the differentiation of the nasopharyngeal squamous cell carcinomas.
研究概览
详细说明
The aim of this study was to depict the applicability of pCLE examinations for diagnosing NPC in comparison to the gold standard of histopathological examination, as well as developed an easy-to-use and straightforward scoring system for the identification of NPC on the basis of morphological and architectural criteria in order to enable a valid and reproducible CLE assessment even for non-experts in their daily clinical practice.
研究类型
介入性
注册 (预期的)
31
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Shanghai
-
Shanghai、Shanghai、中国、200031
- 招聘中
- Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China
-
接触：
- Huawei Li, Phd &MD
- 邮箱：hwli@shmu.edu.cn
-
首席研究员：
- Huawei Li, Phd & MD
-
副研究员：
- Yusu Ni, Phd & MD
-
首席研究员：
- Wenyan Li, Phd & MD
-
副研究员：
- Yunfeng Wang, Phd & MD
-
首席研究员：
- Lingjie Wu, MS & MD
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 85年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Male or female > 18 years of age
- Indicated for nasal endoscope for indeterminate NPC
- Willing and able to comply with study procedures and provide written informed consent to participate in the study
Exclusion Criteria:
- Subjects for whom pCLE procedures are contraindicated
- Known allergy to fluorescein dye
- If female, pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：非随机化
- 介入模型：单组作业
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：normal mucosa
Flat and relatively uniform polygonal epithelial cells with alternating dark and light bands were noted in pCLE images of normal mucosa after intravenous injecting 10% fluorescein.
|
The nasopharyngeal lesions were first identified endoscopically by nasal endoscope.
Then, an initial dose of 0.5 mL prior to the examination with a maximum dose of 2.5 mL of 10% fluorescein (IV; Akorn Inc, Lake Forest, Illinois, USA) during the measurement procedure was defined according to the experiences of workgroup in the gastrointestinal tract.
|
|
实验性的：lymphoid hyperplasia
An unorganized tissue architecture, irregular cells (difference of cell shape, color and size), slightly intensified fluorescein leakage, and vessels not assessable were found in the lymphoid hyperplasia of nasopharyngeal mucosa after intravenous injecting 10% fluorescein..
|
The nasopharyngeal lesions were first identified endoscopically by nasal endoscope.
Then, an initial dose of 0.5 mL prior to the examination with a maximum dose of 2.5 mL of 10% fluorescein (IV; Akorn Inc, Lake Forest, Illinois, USA) during the measurement procedure was defined according to the experiences of workgroup in the gastrointestinal tract.
|
|
实验性的：nasopharyngeal carcinoma
pCLE images of nasopharyngeal carcinoma, which was associated with crowded unorganized tissue architecture (a dark-gray background without identification of mucosal structures), irregular cells like cell clusters, amplified fluorescein leakage, and irregular vessels changes after intravenous injecting 10% fluorescein.
|
The nasopharyngeal lesions were first identified endoscopically by nasal endoscope.
Then, an initial dose of 0.5 mL prior to the examination with a maximum dose of 2.5 mL of 10% fluorescein (IV; Akorn Inc, Lake Forest, Illinois, USA) during the measurement procedure was defined according to the experiences of workgroup in the gastrointestinal tract.
|
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 |
|---|---|---|
|
pCLE classification and scoring system
大体时间：3 months
|
Evaluation of pCLE diagnostic performance for the diagnosis of NPC when associated with other diagnostic information.
|
3 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
the quantitative image analysis
大体时间：3 months
|
Quantitative image features are calculated in the pCLE images
|
3 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Huawei Li, Phd &MD、Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年1月1日
初级完成 (实际的)
2017年12月27日
研究完成 (预期的)
2018年6月30日
研究注册日期
首次提交
2017年6月27日
首先提交符合 QC 标准的
2017年6月27日
首次发布 (实际的)
2017年6月28日
研究记录更新
最后更新发布 (实际的)
2018年2月5日
上次提交的符合 QC 标准的更新
2018年1月31日
最后验证
2018年1月1日
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.
鼻咽癌的临床试验
-
Taichung Veterans General Hospital完全的心脏毒性 | 非小细胞肺癌（MeSH术语：Carcinoma, Non-Small-Cell Lung） | 药物相关副作用和不良反应（MeSH术语） | 表皮生长因子受体酪氨酸激酶抑制剂台湾
-
Fondazione del Piemonte per l'Oncologia招聘中乳腺癌 | 卵巢癌 | 结直肠癌 | 黑色素瘤（皮肤癌） | 非小细胞肺癌（MeSH术语：Carcinoma, Non-Small-Cell Lung）意大利
10% fluorescein的临床试验
-
AerasEuropean and Developing Countries Clinical Trials Partnership (EDCTP)完全的
-
University of OxfordNational Institute of Allergy and Infectious Diseases (NIAID); Wellcome Trust完全的
-
Shanghai Vitalgen BioPharma Co., Ltd.尚未招聘
-
Medical College of WisconsinThe New York Eye & Ear Infirmary完全的