Comparison of Real-time Robotic Arm-assisted 18F-FDG PET/CT-guided Lung Biopsy Versus PET Fused CT- Fluoroscopy-guided Lung Biopsy: a Randomized Trial to Assess Diagnostic Performance and Patient Safety.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- To compare the accuracy ( in percentage) of trans-thoracic percutaneous PET fused CT-fluoroscopy guided lung biopsy and automated robotic arm assisted PET/CT guided lung biopsy
研究概览
简要总结
Patients with suspicious lung lesions were undertaken for PET/CT directed under CT fluoroscopy lung biopsy or robotic-assisted biopsy. The biopsy planning including patient positioning was done after F18-FDG PET/CT whole body or regional imaging of the patient. Written consent was obtained and the patient will be prepared for the biopsy. Lung biopsies were done using a semi-automatic biopsy gun under the imaging guidance (PET fused CT fluoroscopy) following aseptic precautions. Follow-up CT scans were taken post-biopsy. The time consumed for the procedure, radiation exposure to the interventionist, complications and diagnostic yield in both the arms were compared.
详细描述
Patients with clinical suspicion of lung lesions were recruited for FDG PET/CT. Based on the PET/CT findings and clinical details a PET/CT guided biopsy was planned. The patients were assigned to the two arms. In the first arm, participants underwent a robotic-assisted biopsy. In the second arm, participants underwent PET/CT-directed CT fluoroscopy-guided lung biopsy. The biopsy planning including patient positioning was done after F18-FDG PET/CT whole body or regional imaging of the patient. Written consent was obtained and the patient will be prepared for the biopsy. Lung biopsies were done using a semi-automatic biopsy gun under the imaging guidance (PET fused CT fluoroscopy) following aseptic precautions. Follow-up CT scans were taken post-biopsy. The time consumed for the procedure, radiation exposure to the interventionist, complications and diagnostic yield in both the arms were compared.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- 是
入选标准
- •Age >/= 18 years
- •FDG avid amenable lung lesion
- •INR < 1.2 and Platelet counts > 80,000/mm3
排除标准
- •Participants with pre-existing bleeding diathesis like hemophilia, coagulopathy defined by INR ≥ 1.2 and Platelet counts ≤ 80,000/mm3
- •Participants who refuse to provide the written informed consent
- •Signs of hypoperfusion like cyanosis, hypotension etc.
- •Presence of hypoxemia (SpO2 < 95% -measured in a pulse oximeter)
- •Pregnant/Lactating females participants
- •Non-cooperative participants
- •Inaccessible lesions (based on the decision made on pre-biopsy planning)
- •CoVID-19 positive participants
结局指标
主要结局
To compare the accuracy ( in percentage) of trans-thoracic percutaneous PET fused CT-fluoroscopy guided lung biopsy and automated robotic arm assisted PET/CT guided lung biopsy
时间窗: three months
Histology reports of the biopsies were recorded and the mutation analysis, Adequacy of the sample was decided by the pathologist who received the sample and when inadequate, we were notified accordingly by the Department of Pathology. The histopathological results were analyzed. True positive, True negative False-positive and False-negative were calculated for both the groups. The diagnostic accuracy in percentage for both arms will be calculated and compared.
次要结局
- To compare the radiation exposure and complication in the both arms(three months)
研究者
Rajender Kumar
Associate Professor
Post Graduate Institute of Medical Education and Research, Chandigarh