The Feasibility of Low Dose Chest CT for Virtual Bronchoscopy Navigation in Human Patients.
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Concordance rate of VBN simulation results
研究概览
简要总结
Advances in medical imaging technology have made it possible to detect patients with small-sized lung lesions early. Generally, invasive methods such as PCNA were used to diagnose peripheral lung nodule. However, Radial probe endobronchial ultrasonography (RP-EBUS) is widely used in the histological diagnosis of peripheral lung nodule in recent years. In order to carry out RP-EBUS, it is necessary to know the path to the lesion to access it. Conventionally, the path to the peripheral lung nodule is identified by the drawing, but recently, the path is reviewed by the virtual bronchoscopy navigation (VBN) which is reconstructed 3-dimension image using the CT data. Currently, VBN is driven by using raw data acquired using standard thin sectioned chest CT protocol, but the problem is that additional doses of radiation are exposed to patients who have initially discovered lung lesions using low dose CT. Therefore, we conduct a randomized controlled trial to verify the suitability of VBN using the raw data acquired by low dose CT.
详细描述
The standard thin sectioned protocol CT consists of scout, enhanced and non-enhanced image. Therefore, in this study, non-enhanced protocol CT was taken with low dose protocols with three different radiation doses to acquire raw data and drive VBN, and compared with the VBN result driven with raw data obtained with standard protocol. The primary endpoint of this study is to verify the consistency and accuracy of the VBN results driven by the raw data obtained with the low dose protocol CT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Care Provider, Outcomes Assessor)
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
- •Inclusion Criteria:
- •Patients older than 18 years
- •Competent to give informed consent
- •Patients requiring a pathological diagnosis of pulmonary nodules using RP-EBUS.
- •Patients who need chest CT before RP-EBUS.
排除标准
- •Patients who could not receive chest CT
- •Inability to obtain informed consent
- •Patients unable to perform RP-EBUS
研究组 & 干预措施
Low dose chest CT simulation
VBN result driven using raw data acquired with low dose CTs taken with three different protocols
干预措施: Chest CT (Diagnostic Test)
Standard protocol chest CT simulation
VBN result driven using raw data acquired with standard protocol CT
干预措施: Chest CT (Diagnostic Test)
结局指标
主要结局
Concordance rate of VBN simulation results
时间窗: From CT scan to VBN drive (an average of 1 week)
Concordance rate comparing the VBN result driven based on raw data acquired with low dose CTs taken with three different protocols compared to the VBN result driven based on raw data obtained with standard protocol CT.
次要结局
未报告次要终点