ISRCTN18425518进行中（未招募）2 期
Diagnostic accuracy study for OWL-EVO1 as a lung cancer EVOC® probe
Owlstone Medical Limited0 个研究点目标入组 350 人开始时间: 2023年8月11日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 350
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 45-85 years
- •2. Ability to provide informed consent
- •3. Receiving a thoracic CT
排除标准
- •1. Anticipated inability to complete the breath sampling procedure (e.g., inability to maintain adequate ventilation unaided or claustrophobia).
- •2. Received an investigational medical product in the context of a Clinical Trial (CTIMP) during the 28 days prior to administration of the (first) probe.
- •3. Individuals under diagnostic investigation for a potential malignancy other than lung cancer that has not yet reached a conclusive diagnosis*.
- •4. Individuals with an inconclusive lung abnormality (indeterminate pulmonary nodule) on CT-scan requiring CT-based monitoring rather than biopsy and/or treatment.
- •5. Documented history of pulmonary surgery or endobronchial interventional procedures other than biopsy, lavage, or bronchial brushings. These include surgical resection, Video Assisted Thoracic Surgery (VATS), bronchial thermoplasty and coiling, airway stenting or other interventional bronchoscopic procedures.
- •6. Pregnant or breastfeeding women and women of child-bearing potential not using adequate contraceptive methods.
- •7. Individuals under investigation for suspicion of lung cancer who are unlikely to receive a definitive tissue diagnosis of lung cancer prior to treatment (e.g. stereotactic ablative radiotherapy without tissue confirmation).
- •*Note; Individuals with a confirmed cancer diagnosis ARE eligible (such as a diagnosis of prostate cancer now undergoing hormone therapy). Individuals scheduled to attend a cancer screening program; prostate, breast, lung, colon, ARE eligible.
研究者
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