Accurate Planning and Guidance of Bronchoscopy for Lung Cancer Management
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Functionality of CTBD Compensation
研究概览
简要总结
The main objective of this project is to demonstrate the potential of three new technical innovations for improving state-of-the-art bronchoscopy guidance systems.
Through this study, we plan to generate preliminary data that demonstrates the potential of three new innovations for enhancing existing bronchoscopy systems in the live clinical setting.
The goal is to demonstrate the potential of the new innovations: 1. to demonstrate the potential of a new methodology to reduce errors from CT-to-body divergence in the live clinical setting, 2. to demonstrate the potential of the new methodologies to enable live rerouting of a guided bronchoscopy, and 3. to perform automatic real-time mucosal lesion detection during a standard airway examination.
These innovations could potentially improve current image-guided bronchoscopy systems and be used for future robotic bronchoscopy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a planned clinical bronchoscopy to evaluate abnormal lung parenchyma and/or central chest lymph nodes;
- •Radiology images, previously obtained for clinical purposes, that meet technical specifications and are available on our team's Radiology research server or can be uploaded from the Hershey Medical Center clinical image storage system.
- •a clinical CT scan performed at Hershey Medical Center, AND
- •Either one of two additional clinically available scans:
- •CT/PET study OR
- •a clinical CT scan that includes inspiratory and expiratory images
- •Must be able to read, write, and speak English.
排除标准
- •Special classes of subjects that will be excluded are pregnant women because clinical CT scans and CT/PET studies are avoided because of the potential for radiation injury to the fetus.
- •Mentally incompetent subjects will be excluded. They will be identified as such because their treating clinician will have deemed them unable to provide consent for their clinical procedure. The clinical record will indicate whether the patient is providing consent or a surrogate decision-maker has been needed. Patients with a surrogate decision-maker will be excluded.
- •We will exclude prisoners and institutionalized individuals because their autonomy is compromised by their status, and the study provides no direct benefit from which they would be excluded. Individuals who become prisoners or are institutionalized after giving consent but before their diagnostic procedure would also be excluded. Their clinical record will identify if they are in custody.
- •Children are not part of this project because they do not get lung cancer. Therefore, we do not provide processes for meeting requirements for parental permission and child assent.
研究组 & 干预措施
Consented Clinical Bronchoscopy Cohort
Lung cancer patients, scheduled for bronchoscopy, who are consented for bronchoscopy by the Virtual Navigator.
干预措施: Virtual Navigation System (Diagnostic Test)
结局指标
主要结局
Functionality of CTBD Compensation
时间窗: 15 minutes
Establish the functionality of the CTBD compensation methodology during a live guided bronchoscopy to a preselected ROI.
Procedure time of CTBD Compensation
时间窗: 15 minutes
Total live procedure time taken to complete bronchoscope navigation to the ROI.
Functionality of Rerouting Methodology
时间窗: 15 minutes
Functionality of the rerouting methodology during a live guided bronchoscopy to a preselected ROI for the situation that an airway branch along the preplanned airway route to the ROI is unnavigable.
Procedure time of Rerouting Methodology
时间窗: 15 minutes
Total live procedure time taken to complete bronchoscope navigation to the ROI, including rerouting.
Functionality of Rerouting to a new ROI
时间窗: 15 minutes
Functionality of the rerouting methodology during a live guided bronchoscopy to a preselected ROI for the situation where the system is rerouted to a new ROI during navigation.
Procedure time of Rerouting Methodology to a new ROI
时间窗: 15 minutes
Total live procedure time taken to complete bronchoscope navigation to a preselected ROI, including rerouting to a new ROI during navigation.
次要结局
未报告次要终点
研究者
William E. Higgins
Distinguished Professor
Penn State University