Vibration Response Imaging (VRI) in Patients Who Are Potential Candidates for Surgical Resection
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Comparison of ppo FEV1 and ppo DLCO as predicted by VRI with the values as predicted by Q scan
研究概览
简要总结
The primary purpose of the study is to investigate the use of VRI to guide the selection of patients for lung surgery. Perfusion scintigraphy is the current method to assess the fractional contribution of lung function of the remaining lung.
The hypothesis is that VRI can determine quantitative postoperative lung function equally accurately as a quantitative perfusion scan.
详细描述
Primarily, VRI will be compared to perfusion (Q) scan by predicted post-operative (ppo) FEV1 and DLCO as predicted by VRI versus as predicted by Q scan. Secondary, the ppo as predicted by each test will be compared with the actual FEV1 and DLCO at 3 months post-operative; If these two methods provide similar results, VRI will be deemed an acceptable alternative to Q scan for determining patient selection for lung resection. Finally, the patient outcomes (30 day mortality and pulmonary complications) for those patients falling within guideline parameters using the VRI measurement will be analyzed to see if using VRI in clinical practice would indeed allow prediction of satisfactory results (similar to literature benchmarks).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to read, understand, and provide written Informed Consent;
- •Age range of 18-90 years;
- •Potential candidate for at least lobectomy due to lung cancer or other intrathoracic malignancy (either suspected or proven by biopsy). Both open and minimally invasive (thoracoscopic) resections are acceptable.
排除标准
- •Body habitus or skin condition that might prevent the placement of the sound sensors on the back (e.g. severe scoliosis, kyphosis, chest wall deformation, skin lesion on the back or compression fracture);
- •There should be no active pulmonary infection (e.g. pneumonia) at the time of the recordings;
- •Hirsutism unless patient is willing to have back shaved;
- •Potentially contagious skin lesion on the back;
- •Giant bulla (more than 1/3 of the hemithorax or >10cm)
- •Pregnant women
结局指标
主要结局
Comparison of ppo FEV1 and ppo DLCO as predicted by VRI with the values as predicted by Q scan
时间窗: Prior to surgery
次要结局
- Comparison of ppo as predicted by each test with the actual FEV1 and DLCO at 3 months post-operative(3 months after surgery)