A Novel Lung Function Imaging Modality As a Preoperative Evaluation Tool (LIME)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Pre-Surgical Imaging and Post-Surgical Lung Function
研究概览
简要总结
To evaluate the correlation between pre-surgical 4DCT-ventilation imaging and post-surgical lung function.
详细描述
To evaluate the correlation between pre-surgical 4-Dimensional Computed Tomography-ventilation (4DCT-ventilation) imaging and post-surgical lung function. To determine whether 4DCT-ventilation is a better predictor of post-surgical lung function than nuclear medicine imaging using pulmonary function tests (PFTs). To determine whether 4DCT-ventilation is a better predictor of post-surgical lung function than nuclear medicine imaging using quality of life (QOL) questionnaires. Evaluate cost-effectiveness of using 4DCT-ventialtion and VQ scans for pre-surgical assessment. To use longitudinal (pre and post-surgical) 4DCT-ventilation imaging to derive novel post-surgical prediction formulas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision to sign and date the consent form.
- •Stated willingness to comply with all required (non-optional) study procedures and be available for the duration of the study.
- •Be a male or female aged 18 to
- •Patient with lung cancer (presumed or biopsy proven) currently undergoing or having undergone evaluation for resection.
- •Lung function assessment required for pre-surgical evaluation at the discretion of the cardiothoracic surgeon.
- •Life expectancy greater than 3 months.
排除标准
- •1. Patients getting a planned wedge resection as the only thoracic resectional procedure.
研究组 & 干预措施
4DCT-ventilation
The patient will undergo 4DCT imaging. The 4DCT imaging data along with image processing techniques will be used to generate a 4DCT-ventilation map. All surgical decisions will be based on the current standard of care imaging (VQ scans) and not on the 4DCT imaging results.
干预措施: 4DCT-Ventilation (Diagnostic Test)
结局指标
主要结局
Pre-Surgical Imaging and Post-Surgical Lung Function
时间窗: Baseline visit to follow up visit, up to 9 months.
Measure the correlation between pre-surgical 4-Dimensional Computed Tomography-ventilation (4DCT) imaging and post surgical lung function using a Percent Predicted Post-Operative Pulmonary Function Test (%PPO PFT).
次要结局
- Ability of %PPO PFTs(Start of study to end of study, up to 2 years)
- Quality of Life (QOL)(Start of study to end of study, up to 2 years)
- Cost-Effectiveness(Start of study to end of study, up to 2 years)
- Longitudinal Imaging Changes(Start of study to end of study, up to 2 years)