AI-based Low Dose CBCT Reconstruction for Lung Puncture Guidance: A Multicenter Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Number of puncture needles of participants undergoing percutaneous lung puncture procedures.
研究概览
简要总结
The goal of this clinical trial is to learn if AI-based low dose CBCT reconstructed images can guide lung puncture effectively. The main questions it aims to answer are:
- Does the AI-based low dose CBCT reconstruction model reconstruct high quality images?
- Is it possible that low-dose CBCT reconstructed images can guide lung puncture procedures without compromising the efficiency of the procedure? Researchers will compare AI-based low dose CBCT reconstructed images to a placebo (conventional CBCT images) to see if AI-based low dose CBCT reconstructed image can guide lung puncture procedures without compromising the efficiency of the procedure.
Participants will:
- Undergo lung puncture under AI-based low dose CBCT reconstructed images guidance or under conventional CBCT images
- Be followed up for 1 week postoperative to obtain patient complications
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who require CBCT-guided precutaneous lung puncture (PLP) and meet the clinical indications for the procedure.
- •Participants whose physical condition is suitable for PLP.
- •Participants are willing to sign informed consent.
排除标准
- •Participants have metallic implants in the body, which severely affects the image quality.
- •Participants are pregnant or breastfeeding.
- •Participants are unwilling or unable to sign informed consent.
研究组 & 干预措施
AI based CBCT reconstructed images guided lung puncture
Participants in the experimental group undergo AI-based low dose (radiation dose is 1/6th of the dose used in the clinic) CBCT reconstructed images guided lung puncture procedures.
干预措施: AI-based low dose CBCT reconstructed images system (Other)
Conventional CBCT images guided lung puncture
Participants in the experimental group undergo conventional CBCT images guided lung puncture procedures.
干预措施: Conventional CBCT images system (Other)
结局指标
主要结局
Number of puncture needles of participants undergoing percutaneous lung puncture procedures.
时间窗: From enrollment to the end of the lung puncture procedure.
The number of punctures was defined as the number of punctures performed throughout the percutaneous lung puncture procedure.
次要结局
- Radiation Dose(From enrollment to the end of the lung puncture procedure.)
- Intraoperative and postoperative complications of participants undergoing lung puncture procedures(From enrollment to the end of the lung puncture procedure at 1 week.)