EUCTR2019-003052-36-GB进行中（未招募）1 期
Triple Modality Functional Magnetic Resonance Lung Imaging in Cystic Fibrosis and Non-CF Bronchiectasis - MRI in Bronchiectasis
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •For this study, eligibility criteria have been separated into workstreams as follows:
- •Workstream 1 – Adult Healthy Volunteers
- •Workstream 2 – Adults with CF
- •Workstream 3 – Adults with Bronchiectasis
- •Workstream 4 – Children aged 12 to less than 16 years with CF
- •Workstream 1
- •(Adult Healthy Volunteers)
- •Aged 16 years and over
- •For women, a negative urinary pregnancy test at screening and study visits
- •No significant respiratory disease or other significant medical condition within the last year
- •Workstreams 2 and 3
- •(Adults with diagnosed Cystic Fibrosis or non-CF Bronchiectasis)
- •Aged 16 years and over
- •For women, a negative urinary pregnancy test at screening and study visits
- •Diagnosis of cystic fibrosis by a respiratory physician (workstream 2) or bronchiectasis by computer tomography (CT) scan or a respiratory physician (workstream 3)
- •Clinically stable as defined by respiratory care team
- •Workstream 4
- •(Paediatric patients with diagnosed Cystic Fibrosis)
- •Parent or legal guardian able to give informed consent
- •Aged 12 years to less than 16 years
- •For females of child bearing age, a negative urinary pregnancy test at screening and study visits
- •Diagnosis of cystic fibrosis by a paediatric respiratory physician
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Workstream 1
- •(Adult Healthy Volunteers)
- •Standard MRI exclusion criteria – a history of implanted / indwelling magnetically active material
- •Acute respiratory illness within 30 days of MRI
- •Subject has received an Investigational Medical Product (not including hyperpolarized 129Xe) within 30 days of MRI and administration of 129Xe deemed inappropriate in context of other study
- •Subject not deemed fit enough to tolerate procedure
- •Subject deemed unsuitable by clinical investigator for other reasons
- •Workstreams 2 and 3
- •(Adults with diagnosed Cystic Fibrosis or non-CF Bronchiectasis)
- •Standard MRI exclusion criteria – a history of implanted / indwelling magnetically active material
- •A current pulmonary exacerbation considered to be of sufficient severity to prevent safe MRI scanning
- •Current infection or previous infection within the last 12 months with Burkholderia cepacia complex or Mycobacterium abscessus
- •Previous lung transplantation
- •Evidence of susceptibility to or established hypercapnic (type 2) respiratory failure
- •Subject has received an IMP (not including hyperpolarized 129Xe) within 30 days of MRI and administration of 129Xe deemed inappropriate in context of other study
- •Subject not deemed fit enough to tolerate procedure
- •Subject deemed unsuitable by clinical investigator for other reasons
- •Workstream 4
- •(Paediatric patients with diagnosed Cystic Fibrosis)
- •Standard MRI exclusion criteria – a history of implanted / indwelling magnetically active material
- •A current pulmonary exacerbation considered to be of sufficient severity to prevent safe MRI scanning
- •Current or previous infection/colonization with Burkholderia cepacia complex or Mycobacteria abscessus
- •Previous lung transplantation
- •Evidence of susceptibility to or established hypercapnic (type 2) respiratory failure
- •Subject has received an IMP (not including hyperpolarized 129Xe) within 30 days of MRI and administration of 129Xe deemed inappropriate in context of other study
- •Subject not deemed fit enough to tolerate procedure
- •Subject deemed unsuitable by clinical investigator for other reasons
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