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临床试验/NCT04299542
NCT04299542已完成不适用

Percutaneous Lung Biopsy Using Cone Beam CT With Virtual Guidance: a Randomized Control Trial

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2020年5月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
1
主要终点
The number of needle repositioning to reach the target

研究概览

简要总结

Image-guided percutaneous lung biopsy is an essential procedure in lung cancer management, where it is integral to confirming the diagnosis and determining tumour histology. An ideal percutaneous lung biopsy also needs to have a short procedure time with accurate needle placement to minimize the inherent risk of the procedure.

Since the 1970s, conventional Multi-detector CT (MDCT) has been the modality of choice in percutaneous lung biopsy. Recent research has proposed CT fluoroscopy and cone-beam CT (CBCT) as alternative methods.

Virtual guidance has been developed to improve target visibility and access for these complex cases. More specifically, it plans a potential computed 3D needle path before the procedure, using the CBCT images. This 3D path can be transposed onto real time fluoroscopic images to guide the biopsy, thus potentially improves patients' safety due to more accurate needle placement.

详细描述

Image-guided percutaneous lung biopsy is an essential procedure in lung cancer management, where it is integral to confirming the diagnosis and determining tumour histology. In this era of personalized medicine where knowledge of specific cellular pathways and molecular characterization relies on obtaining optimal tissue sampling, the critical question is how to obtain a high-quality biopsy tissue sample that could be processed for various pathological assessment from a single, minimally invasive percutaneous image-guided approach.

An ideal percutaneous lung biopsy also needs to have a short procedure time with accurate needle placement to minimize the inherent risk of the procedure, including the stochastic effect of radiation, and injuries to structures resulting in pneumothorax, pulmonary hemorrhage, and air embolism, which could all be potentially life threatening. Previous studies have also shown that post-biopsy haemorrhage or pneumothorax requiring chest tubes insertion had worse outcome, increased length of hospital stays, and respiratory failure.

Since the 1970s, conventional Multi-detector CT (MDCT) has been the modality of choice in percutaneous lung biopsy, which requires repeated scanning of the target lesion during the procedure and the interventional radiologist entering and leaving the CT suite after each needle adjustment. Recent research has proposed CT fluoroscopy and cone-beam CT (CBCT) as alternative methods.

Virtual guidance has been developed to improve target visibility and access for these complex cases. This involves image registration where the real-time imaging dataset is matched to a reference dataset, where the position of a device is displayed on the current imaging dataset in real time. Syngo iGuideTM is a novel navigational software which has the potential for accurate needle guidance in percutaneous biopsy. More specifically, it plans a potential computed 3D needle path before the procedure, using the CBCT images. An integrated laser crosshair is also projected onto the patient's skin to indicate the entry point and angle of the needle at no additional radiation dose to the patient and staff. This 3D path can be transposed onto real time fluoroscopic images to guide the biopsy, thus potentially improves patients' safety due to more accurate needle placement.

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
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

入选标准

  • Solitary or multiple lung lesions (solid or subsolid nodule, pulmonary infiltrate) ≥1cm

排除标准

  • Patient <18 years old
  • Patient not able to give informed consent
  • Uncooperative patient who is unable to hold still or hold their breath for safe biopsy
  • Lesions <1cm
  • Lesions within 1cm of vital thoracic structures such as the great vessels and the mediastinum
  • Peripheral lesions accessible to biopsy with ultrasound guidance

结局指标

主要结局

The number of needle repositioning to reach the target

时间窗: immediately after completion of procedure

This will be recorded during procedure

次要结局

  • procedure time(immediately after completion of procedure)
  • radiation dose(immediately after completion of procedure)
  • complication(1 month after completion of procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Simon Yu

Professor

Chinese University of Hong Kong

研究点 (1)

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