Prevalence and Clinical Relevance of Ventilation Heterogeneity and Luminal Cellular Inflammation in Lung Cancer Patients Prior to Lung Resection
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Abnormal ventilation heterogeneity assessed by 129Xe MRI
研究概览
简要总结
This is a single centre prospective six-week observational study to understand the prevalence and clinical relevance of abnormal ventilation of the lung (assessed by Technegas ventilation single photon emission computed tomography (V SPECT) and hyperpolarized 129Xe magnetic resonance imaging (MRI)), in the presence or absence of airway inflammation (assessed by sputum cell counts), in lung cancer patients prior to lung resection surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Undergoing lung resection for lung cancer at St. Joseph's Healthcare (Hamilton, Ontario) in accordance with British Thoracic Society guidelines.
- •Males and females ≥ 18 years of age.
- •Able and willing to provide written informed consent.
- •Able and willing to comply with the study protocol.
排除标准
- •Previous lung resection surgery.
- •Previous chest radiation.
- •Patient has an implanted mechanically, electrically or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples.
- •In the investigator's opinion, subject suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI, such as severe claustrophobia.
- •Pregnancy.
结局指标
主要结局
Abnormal ventilation heterogeneity assessed by 129Xe MRI
时间窗: Baseline
Proportion of patients with abnormal ventilation heterogeneity, assessed by 129Xe MRI, prior to lung resection for lung cancer.
Abnormal ventilation heterogeneity assessed by Technegas V SPECT
时间窗: Baseline
Proportion of patients with abnormal ventilation heterogeneity, assessed by Technegas V SPECT, prior to lung resection for lung cancer.
次要结局
- Incidence of post-operative pulmonary complications (PPC): Technegas V SPECT ventilation heterogeneity(up to 4 weeks)
- Incidence of PPC: Technegas V SPECT ventilation heterogeneity and luminal cellular inflammation(up to 4 weeks)
- Technegas V SPECT ventilation heterogeneity and luminal cellular inflammation(Baseline)
- 129Xe MRI ventilation heterogeneity and luminal cellular inflammation(Baseline)
- Incidence of PPC: 129Xe MRI ventilation heterogeneity(up to 4 weeks)
- Incidence of PPC: 129Xe MRI ventilation heterogeneity and luminal cellular inflammation(up to 4 weeks)