LUng voluMe reductIoN by DuAl ENergy CT Evaluation (LUMINANCE) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Change in walk distance as measured by six-minute walk test
研究概览
简要总结
The purpose of this research study is to see if a special CT scan (dual-energy CT) provides useful information in patients undergoing bronchsoscopic lung volume reduction (valve placement for emphysema). The investigators will enroll up to 30 participants in this study from University Hospitals Cleveland Medical Center. All of the participants from this study will undergo their valve procedure at University Hospitals Cleveland Medical Center.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Adult patients (≥ 18 years of age at the time of written informed consent) with emphysema who have been deemed appropriate candidates for bronchoscopic lung volume reduction
排除标准
- •Patients unable to provide consent
- •Patients who are pregnant or nursing
- •Women of child-bearing age will undergo pregnancy tests based on University Hospital (UH) standard bronchoscopy pre-procedural testing
- •Patients unable to undergo a DECT chest (contraindications to a CT chest with intravenous contrast such as a reported or documented allergy to intravenous (IV) contrast or impaired renal function, defined as the following:
- •Glomerular filtration rate (GFR) <90 ml/min/1.73 m2 at the time of initial evaluation if patient age is ≤ 59 years
- •GFR <85 ml/min/1.73 m2 if patient age is 60-69 years
- •GFR <75 ml/min/1.73 m2 if patient age is ≥70 years
结局指标
主要结局
Change in walk distance as measured by six-minute walk test
时间窗: Baseline, 8 weeks
Change in FEV1 as measured by pulmonary function test
时间窗: Baseline, 8 weeks
Change in lung perfusion as measured by duel-energy computed tomography
时间窗: Baseline, 8 weeks
次要结局
未报告次要终点
研究者
Sameer Avasarala
Assistant Professor of Medicine, Case Western Reserve University School of Medicine
University Hospitals Cleveland Medical Center