Vibration Response Imaging (VRI) in the Preoperative Management in Patients With Non-Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- lung function testing diffusion capacity VRI
研究概览
简要总结
The purpose of this study is to assess the correlation of the predicted post-operative lung function with the observed post-operative lung function (FEV1 and DLCO) in patients who underwent surgical resection (FEV1 = Forced expiratory volume in 1-second. DLCO = Diffusion capacity for carbon monoxide. ppo = predicted postoperative.)and versus the gold standard QRRVP (Quantitative Radionuclide Study of Regional Lung Ventilation and Perfusion)
详细描述
The current standard lung function test uses radioisotopes (materials that produce radiation) injected in a vein and breathed into the lungs, which can show images of the function of the lungs.
The VRI system uses pressure sensors that act like electronic stethoscopes (tools used by doctors to listen to the heart and other sounds in the body). These sensors can record the energy (vibrations) created by the airflow in the lungs during the breathing process, which can then be visually imaged.
Before you can start this study, there will be a screening evaluation. The study doctor will review your medical record to find out if you are eligible to take part in this study. Information that will be viewed will include whether you have a skin lesion that might interfere with sensor placement, whether you have a cardiac pacemaker, and/or pregnancy test results. The study doctor will review with you the other types of information that will be viewed from your medical record to find out if you are eligible to take part in this study. For women who are able to have children, if you do not have a negative pregnancy test result in your medical record, you will not be able to take part in this study.
If you are found to be eligible and you agree to take part in this study, you will have a lung function test with the VRI system immediately before or after the standard lung function test. To perform the VRI test, you will be asked to remove your shirt and put on a garment to cover the front of your body. You will also be asked to remove your jewelry and other body accessories. You will then be asked to sit on a backless chair, and you will be instructed how to sit with the proper posture and breathe correctly for this test.
Before recording starts, the sensors will be cleaned and then placed on your back. You will be instructed to breathe deeply for up to 12 seconds (about 2-3 times), and the vibration responses will be recorded. You will have a total of 3 recording sessions, one after the other. Once all the recording is done, the sensors will be removed. The VRI image of the vibrations will then be examined by the operator in order to check the quality of the image.
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
- 35 Years 至 80 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, and
- •Male or Female in the age range 18-90 years, and
- •Referred to perform QRRVP test for pre lung surgery evaluation due to lung cancer or other intrathoracic malignancy, and
- •BMI (body mass index) equal to or greater than 19
排除标准
- •Chest wall deformation, or
- •Spine deformation (including severe scoliosis), or
- •Hirsutism on back, or
- •Potentially contagious skin lesion on the back, or
- •Skin lesion that would interfere with sensor placement, or
- •Cardiac pacemaker or implantable defibrillator
- •Pregnancy (all women of childbearing age must have a negative pregnancy test before beginning the study) or breast feeding
结局指标
主要结局
lung function testing diffusion capacity VRI
时间窗: pre- 6 weeks post and 3 month postoperative
次要结局
未报告次要终点