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The Translational Research Image-Guided Operating Room (TRIGORA): Intraoperative 3D Imaging for Head & Neck Surgical Patients (TRIGORA)

2019年12月3日 更新者:University Health Network, Toronto

Head and neck cancer surgery presents the challenge of tumour resection in close proximity to critical structures such as the carotid arteries and optic nerves. The need for precise localization within complex 3D anatomy has motivated the development of image-guidance systems that account for tissue deformation and excision through the use of intraoperative cone-beam CT (CBCT). A prototype mobile C-arm for intraoperative flat-panel CBCT has been developed at UHN in collaboration with Siemens Healthcare to provide low-dose 3D images with sub-mm spatial resolution and soft-tissue visibility. Extensive investigation in pre-clinical/clinical H&N, otology, orthopaedic, lung, and spine surgery has demonstrated the benefit of intraoperative CBCT for improved target ablation, localization accuracy, and critical structure avoidance.

Prospective clinical trial in CBCT-guided H&N surgery will be conducted to evaluate the Zeego robotic platform for CBCT. Patient accrual will span a wide range of surgical procedures in otolaryngology, including cancer resection and anatomical reconstruction in the mandible, maxilla, sinuses, skull base, and temporal bone. The effect of intraoperative imaging and surgical guidance on logistical considerations of time, workflow, and compatibility with the OR environment will be evaluated through the use of in-room audio/video recordings, human factors engineering methods, and expert feedback questionnaires obtained from the surgeons, nurses, and anesthetists involved in each case. This clinical investigation will help to further define indications for CBCT-guided H&N surgery, and serve to enable the development of surgical task-specific imaging protocols.

研究概览

地位

完全的

条件

详细说明

For each patient enrolled in this study, the following administrative information will be compiled and maintained by the Principal Investigator at Princess Margaret Hospital:

Consent Form: The signed consent form. (Note that the Consent Form is the only information collected in this study that is not anonymous. All subsequent information is identified by an arbitrary Code # that can not be directly or indirectly traced back to the individual patient.) Clinical Summary: A brief summary provided by the Clinical Co-Investigator and/or Surgical Fellow regarding the patient's illness and prescribed surgical treatment plan. The Clinical Summary is anonymous with respect to patient identity and will be identified by an arbitrary Code #. The Summary will include age, weight, height, sex, diagnosis, stage, habits (viz., smoking and alcohol consumption), results of physical examination, and relevant medical history (e.g., prior surgery). This will also include medical history related to suitability for IV contrast (see the form included with the protocol).

Procedure Log: A summary log of the surgical procedure and imaging studies, when and where they were carried out, and relevant notes regarding the surgical and imaging procedures therein e.g., success or failure of the treatment plan or imaging system, etc. The Procedure Log is also anonymous and identified by an arbitrary Code #.

研究类型

观察性的

注册 (实际的)

48

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

    • Ontario
      • Toronto、Ontario、加拿大、M5G2M9
        • University Health Network

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

取样方法

概率样本

研究人群

Patients undergoing surgery to the head and neck and deemed eligible for this study by the investigators.

描述

Inclusion Criteria:

  • The study will include patients with tumors or other masses in the following sites, nasal cavity, sinuses, nasopharynx, parapharyngeal space, deep parotid salivary glands, oral cavity, oropharynx, and skull base. Cases considered in this study will include lesions in one or several of these sites.

The patients are intended to undergo surgical treatment for their disease. The patients should have a complete and detailed medical record. Subjects must be at least 18 years of age. Subjects must sign and be given a copy of the written Informed Consent Form.

Exclusion Criteria:

  • Patients with unresectable lesions, where surgery is not the treatment of choice.

Patients who are not able to consent by themselves or grasp the implication of the study.

Subjects participating in any other clinical trial during the time of this clinical investigation and that may have an impact on this evaluation.

Subjects may be excluded from this study at the discretion of a Clinical Co-Investigator, if they are enrolled in other studies that will result in combined radiation exposure exceeding standard of care.

Subjects who are pregnant, lactating, or planning to become pregnant during the period of the evaluation.

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

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
Evaluation of 3D cone-beam imaging
大体时间:intraoperative
Evaluate the performance of 3D cone-beam imaging in the operating room
intraoperative

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。

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)

2012年10月4日

初级完成 (实际的)

2019年3月31日

研究完成 (实际的)

2019年3月31日

研究注册日期

首次提交

2017年11月14日

首先提交符合 QC 标准的

2017年11月14日

首次发布 (实际的)

2017年11月17日

研究记录更新

最后更新发布 (实际的)

2019年12月4日

上次提交的符合 QC 标准的更新

2019年12月3日

最后验证

2019年12月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 12-5315

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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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