PET/CT GUIDED BIOPSY VERSUS CT GUIDED BIOPSY IN EVALUATION OF SUSPECTED LUNG NEOPLASMS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Inconclusive pathology findings
研究概览
简要总结
Percutaneous CT guided biopsy is a well-established, standard sampling technique for suspected neoplastic lesions located in peripheral region in lung parenchyma. Inconclusive results on CT guided biopsy is substantially higher in large lung lesions which are prone to cause peripheral pneumonia, atelectasis and even regional necrosis, which are hard to be distinguished from tumor on CT images.
Functional imaging guided biopsy like PET/CT guided biopsy identifies areas of highest concentration of neoplastic cells and provides accurate results. Only a few studies have been done regarding PET/CT guided biopsy and studies omparing PET/CT guided and CT guided percutaneous transthoracic lung biopsy are very few and this study would be a randomized trial comparing these diagnostic modalities in terms of diagnostic yield, diagnostic accuracy of sample and complications.
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
- 否
入选标准
- •Age above 18 years
- •INR < 1.2 and platelet counts > 80,000/mm3
- •CT thorax with lung lesion more than 10 mm.
- •Accessible lesions for CT-guided biopsy.
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 consent
- •Signs of hypoperfusion like hypotension, cyanosis etc.
- •Presence of hypoxemia with SpO2 < 94 %- measured in a pulse oximeter)
- •Pregnant/Lactating female subjects
- •Non-cooperative subjects
- •Lesions that are inaccessible (decision made on pre-biopsy planning)
- •Serum creatinine level more than 2mg/dl.
研究组 & 干预措施
PET-CT guided biopsy
干预措施: PET-CT guided biopsy (Procedure)
CT guided biopsy
干预措施: CT guided biopsy (Procedure)
结局指标
主要结局
Inconclusive pathology findings
时间窗: 1 month
Comparing the proportion of inconclusive pathology reports in both arms
次要结局
- Incidence of pneumothorax and hemoptysis(1 month)
研究者
Girish Kumar Parida
Assistant Professor
All India Institute of Medical Sciences, Bhubaneswar