CTIS2023-503574-20-00招募中1 期
Diagnostic Accuracy Study for OWL-EVO1 as a Lung Cancer EVOC® Probe - OML-EV2-2.1_E
Owlstone Medical Limited0 个研究点目标入组 175 人开始时间: 2023年7月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 175
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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Aged 45-85 years, Ability to provide informed consent, BMI 16 - <40, Receiving a CT including the thoracic region, within the last 6 months
排除标准
- •(Anticipated) inability to complete the breath sampling procedure (e.g., inability to maintain adequate ventilation unaided or claustrophobia)., Potential subjects if in the opinion of the investigator lack mental capacity, Received an investigational medical product in the context of a Clinical Trial (CTIMP) during the 28 days prior to administration of the (first) probe, or within 5 times the half-life of the investigational medicinal product previously received, whichever is longer, Individuals under diagnostic investigation for a potential malignancy other than lung cancer that has not yet reached a conclusive diagnosis, Individuals with an inconclusive lung abnormality (indeterminate pulmonary nodule) on CT-scan requiring CT-based monitoring rather than biopsy and/or treatment, 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, Pregnant or breastfeeding women and women of child-bearing potential not using adequate contraceptive methods (Subjects must agree to use contraception for 2 months post last dose), 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), Further to the above stated exclusion criteria, in the interest of subject safety, exclusion of any subject is at the ultimate discretion of the investigator. This includes (but is not limited to) subjects who are acutely unwell according to investigator assessment.
研究者
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