ISRCTN14024829已完成未知
Randomised controlled trial to compare the diagnostic yield of Positron Emission Tomography Computerised Tomography (PET CT) targeted pleural biopsy versus CT-guided pleural biopsy in suspected pleural malignancy
orth Bristol NHS Trust0 个研究点目标入组 78 人开始时间: 2016年1月27日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 78
研究概览
简要总结
2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29616141 protocol 2024 Results article in https://doi.org/10.1183/13993003.01295-2023 (added 13/02/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 17/11/2017:
- •Participants may be eligible for the study if ALL the following apply:
- •1. Pleural thickening on CT suspicious for pleural malignancy
- •2. Have had any form of pleural biopsy in the last 12 months (either by thoracoscopy or under radiological guidance) which was non-diagnostic for cancer
- •3. Lung Cancer/mesothelioma MDT decision to perform further CT-guided biopsy to pursue a diagnosis
- •Previous participant inclusion criteria:
- •1. Aged 18 years or over
- •2. Pleural thickening on CT suspicious for malignancy
- •3. Have had any for of pleural biopsy in the last 6 months (either by thoracoscopy or under radiological guidance) which was nondiagnostic for cancer
- •4. Lung Cancer/Mesothelioma Multidisciplinary team (MDT) decision to perform further CT guided biopsy to pursue a diagnosis
排除标准
- •Current exclusion criteria as of 17/11/2017:
- •Participants may not enter study if ANY of the following apply:
- •1. Unsuitable for a CT guided biopsy – inability to co-operate, lie still for the duration of the biopsy, uncorrectable coagulopathy, inability to tolerate a pneumothorax, severe underlying lung disease (patients with an FEV1 < 35% assessed using simple spirometry, see section 5.3.1)
- •2. Unable to give written informed consent
- •3. Pregnancy or lactation
- •4. Age <18 years
- •5. Pleural thickening not amenable to a radiologically guided biopsy
- •6. Talc pleurodesis in the previous 6 months
- •Previous exclusion criteria:
- •1. Unsuitable for CT guided biopsy inability to cooperate, lie still for the duration of the biopsy, uncorrectable coagulopathy, inability to tolerate a pneumothorax, severe underlying lung disease (patients with an FEV1 <35% assessed using simple spirometry)
- •2. Unable to give written informed consent
- •3. Pregnancy or lactation
- •4. Aged under 18 years
- •5. Pleural thickening not amenable to Trucut biopsy
- •6. Prior Talc pleurodesis
研究者
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