Feasibility Study of Anatomical Modeling for Image Guided Thoracic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Feasibility of anatomical modeling for image guided thoracic surgery
研究概览
简要总结
This clinical trial assesses the feasibility of creating a 3 dimensional (D) model of the lung and lung nodule(s) from computed tomography (CT) scan images performed during lung surgery. Unlike solid organs (like the kidney, brain, and liver), the lung changes shape (they inflate when a person breathe in and collapse when they breathe out). This makes it difficult to predict where, exactly, the tumor(s) will be on the lungs during surgery. A 3D model may help surgeons better predict where the location of the tumor(s) will be during surgery.
详细描述
PRIMARY OBJECTIVE:
I. To assess the feasibility of developing an anatomical model to predict the location of the tumor in a deflated lung to assist in guidance during lung surgery.
SECONDARY OBJECTIVES:
I. Develop a registration technique to register the tumor onto the 2D/3D optical image obtained during surgery.
II. Determine the accuracy of mapping major segmental vasculature and bronchial structures onto 2D/3D optical images obtained during surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Patients must have previous CT images demonstrating a lung mass or masses amenable to lung resection (open or minimally invasive)
- •Patient is scheduled for surgical resection in a room equipped with intraoperative CT
- •Patient must sign informed consent, with risks and benefits of CT imaging explained
- •Patients with lung tumors >= 1cm to =< 3 cm based on preoperative CT scan. (Patients with lung tumors from < 1 cm or > 3 cm will be reviewed and approved for inclusion on an individual assessment by clinical collaborators)
排除标准
- •Pediatric patients less than 18 years of age
- •Patients who have undergone previous ipsilateral thoracic surgery, sclerotherapy, or radiation therapy as intraoperative adhesions may limit lung collapse intraoperatively
- •Patients who received neoadjuvant immunotherapy
- •Women who are pregnant or nursing
研究组 & 干预措施
Diagnostic (CT)
Patients undergo 4 CT scans during standard of care surgery.
干预措施: Computed Tomography (Procedure)
Diagnostic (CT)
Patients undergo 4 CT scans during standard of care surgery.
干预措施: Therapeutic Conventional Surgery (Procedure)
结局指标
主要结局
Feasibility of anatomical modeling for image guided thoracic surgery
时间窗: Up to 1 year
The geometrical accuracy of the models for localizing the tumor will be quantified. The study is feasible if tumors for all 10 patients can be located with accuracy of within 1 cm or less. Anatomical modeling for image guided thoracic surgery will be considered feasible if researchers are able to determine the location of the tumor in a deflated lung to within the accuracy required by the surgeon for clinical use.
次要结局
未报告次要终点