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Minimally Invasive Imagery With Indocyanine Green (ICG)

2018年3月16日 更新者：Sunil Singhall、University of Pennsylvania

A Pilot & Feasibility Study of the Imaging Potential of Indocyanine Green in Subjects Undergoing Minimally Invasive Thoracic Surgery Presenting With Thoracic Nodules

Determine if ICG administered pre-operatively, then imaged intraoperatively using our cameras, will aid in the identification of a suspected thoracic nodules, margins, lymph nodes and satellite nodules during minimally invasive procedures. The investigators intend on enrolling 48 Subjects in this study. The study is focusing on patients presenting with suspected thoracic cancers who are considered to be good minimally invasive surgical candidates

研究概览

地位

完全的

条件

干预/治疗

详细说明

According to the World Health Organization, lung cancer is the most common cause of cancer-related death in men and women, and is responsible for 1.3 million deaths worldwide annually as of 2004.

Surgery remains the best option for patients presenting with operable Stage I or II cancers, however the five year survival rate for these candidates remains at a dismal 53% for Stage I and 32% for Stage II (1). The high rates of recurrence suggest that surgeons are unable to completely detect and remove primary tumor nodules in a satisfactory manner as well as lingering metastases in sentinel lymph nodes. By ensuring a negative margin through near-infrared imagery it would be possible for us to improve the rates of recurrence free patients and thus overall survival.

The use of an ICG probe will allow for the operating field and lung tissue to be observed in real-time.

ICG has been used in the clinical settings since 1957. There is a wealth of data available attesting to the safety of this drug injected at its current clinically indicated dosing level. ICG has been shown to preferentially uptake in esophageal tumors as opposed to surrounding epithelial lumen after one minute of IV exposure (2). Additionally, the same group reported being able to better characterize the vascularization of the tumor to further clarify the invasiveness of the cancer. ICG usage has been shown to be safe in a similar clinical setting by the Gotoh group, who used ICG to detect and characterize bullous and emphysematous lesion of the lung in video assisted thoracoscopic surgeries (VATS) with Infrared Thoracoscopy that were not previously detectable by white light (3).

The currently proposed trial is a single center, open-label pilot/observational cohort study. Patients with a diagnosis of resectable thoracic nodule/mass who are presumed to be resectable via minimally invasive surgery as determined by pre-operative assessment at the Hospital of the University of Pennsylvania will be included.

研究类型

介入性

注册 (实际的)

48

阶段

  • 阶段1

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

  • 美国
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • Hospital of the University of Pennsylvania

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 及以上 (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:

  1. Adult patients over 18 years of age
  2. Patients presenting with a thoracic nodule presumed to be resectable cancer on pre-operative assessment
  3. Good minimally invasive operative candidates as determined by a thoracic oncology multidisciplinary team
  4. Subject capable of giving informed consent and participating in the process of consent.

Exclusion Criteria:

  1. Pregnant women as determined by urinary or serum beta human chorionic gonadotropin (hCG) within 72 hours of surgery
  2. Subjects with a history of iodide allergies

  3. At-risk patient populations

    1. Homeless patients
    2. Patients with drug or alcohol dependence
    3. Children and neonates
    4. Patients unable to participate in the consent process

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：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
实验性的：Indocyanine Green
Dosage calculated by weight of individual, 5mg/kg.
药品：Indocyanine Green
Infusion of ICG 24 hours prior to surgery
其他名称：
  • ICG

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
Ability of imaging system to detect expression of ICG in nodule/mass (i.e. tumor) and discern uptake of dye by tumor
大体时间：36 months
Detected with imaging probe during minimally invasive procedure
36 months

次要结果测量

结果测量
大体时间
Incidence rates of all adverse events, treatment-emergent adverse events, and adverse device events from time of ICG administration through participants' first, post-operative appointment with surgeon
大体时间：36 Months
36 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。

赞助

University of Pennsylvania

调查人员

  • 首席研究员：Sunil Singhal, MD、University of Pennsylvania

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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

2014年11月1日

初级完成 (实际的)

2016年11月1日

研究完成 (实际的)

2016年11月1日

研究注册日期

首次提交

2015年12月1日

首先提交符合 QC 标准的

2015年12月1日

首次发布 (估计)

2015年12月3日

研究记录更新

最后更新发布 (实际的)

2018年3月20日

上次提交的符合 QC 标准的更新

2018年3月16日

最后验证

2018年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • 820766

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.

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