A Pilot Study to Evaluate Percussive Ventilation Breathhold to Improve Lung Stereotactic Ablative Radiotherapy (PVB-SABR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Rate of successful Percussive Ventilation Breathhold (PVB) maneuver in healthy volunteers.
研究概览
简要总结
The purpose of this research is to evaluate and determine the rate of successful administration of Percussive ventilation breathhold (PVB) to allow for more accurate radiotherapy for lung tumors.
详细描述
Primary Objective(s)
- To determine the rate of successful administration of the PVB-SABR in lung cancer patients.
- To determine the rate of successful administration of PVB in healthy volunteers for 5 minutes
Secondary Objective(s)
- To determine the rate of successful administration of PVB in healthy volunteers for 10 minutes as well as for patients' successfully completing the technique for 5 and 10 minutes.
- To collect exploratory clinical (both arms) and dosimetric data from lung cancer patients using PVB-SABR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Arm 1: Healthy volunteers age 18 or older
- •Arm 1: Ability to understand and the willingness to sign (personally or by a legal authorized representative) the written IRB approved informed consent document.
- •Arm 2: Patients with a diagnosis of primary lung cancer or lung metastases of any primary tumor origin
- •Arm 2: Patients deemed clinically eligible to be treated with standard of care lung SABR for patient arm
- •Arm 2: Patients of any gender age 18 or older
- •Arm 2: Patients with ECOG Performance Status 0-2 and select patients with Performance Status 3 deemed to be suitable candidates based on common sense clinical judgment on the risks versus benefits of SABR
- •Arm 2: Ability to understand and the willingness to sign (personally or by a legal authorized representative) the written IRB approved informed consent document.
排除标准
- •Arm 1: No Pregnant Individuals. All individuals of child bearing potential (last menstrual period within the previous 12 months and not surgically sterile) will be tested for pregnancy and documented by study team.
- •Arm 2: Patients clinically deemed ineligible for standard of care lung SABR treatment for the patient arm (for example, excessive tumor size, individuals who are pregnant or breast feeding, severe pulmonary fibrosis are relative contraindications for lung SABR and are part of standard of care clinical decision making).
- •Arm 2: Patients with newly-developed pneumothorax
- •Arm 2: Patients with critical acute illness precluding SABR in the judgment of the treating physician (examples could include active pulmonary embolism and infection requiring inpatient care)
- •Arm 2: Patients with ECOG Performance Status 4
研究组 & 干预措施
Administration of Percussive ventilation breathhold (PVB) technique in healthy volunteers
The healthy patient will execute the Percussive ventilation breathhold technique
干预措施: Percussive Ventilation Breathhold SABR (PVB-SABR) (Other)
Administration of the PVB-SABR in lung cancer patients
Lung cancer patients will execute a PV breathhold and a verification cone-beam CT scan.
干预措施: Percussive Ventilation Breathhold SABR (PVB-SABR) (Other)
结局指标
主要结局
Rate of successful Percussive Ventilation Breathhold (PVB) maneuver in healthy volunteers.
时间窗: 18 months
The rate will be measured as the proportion of healthy volunteers who can be successfully execute the Percussive Ventilation Breathhold for 5 minutes. In the event of a failure, both investigator and patient will be asked to specify the reason for failure for purposes of failure analysis.
Rate of successful administration of Percussive Ventilation Breathhold Stereotactic Ablative Radiotherapy (PVB SABR) in lung patients.
时间窗: 18 months
The rate will be measured as the proportion of lung cancer patients who successfully complete treatment using the PVB SABR method as defined by 100% of the prescribed Stereotactic Ablative Radiotherapy dose being delivered using the Percussive Ventilation Breathhold (PVB) technique. A failure will be defined as a patient who fails to use the method for any part of the treatment. In the event of a failure, both investigator and patient will be asked to specify the reason for failure for purposes of failure analysis.
The rate of successful Percussive Ventilation (PV) breathhold maneuver in healthy volunteers.
时间窗: Day 1 (at Mock simulation visit)
The rate will be measured as the proportion of healthy volunteers who can be successfully execute the PV breathhold for 5 minutes. In the event of a failure, both investigator and patient will be asked to specify the reason for failure for purposes of failure analysis.
The rate of successful administration of Percussive Ventilation Breathhold (PVB) Stereotactic Ablative Radiotherapy (SABR) in lung patients.
时间窗: Perioperative/Periprocedural
The rate will be measured as the proportion of lung cancer patients who successfully complete treatment using the PVB SABR method as defined by 100% of the prescribed SABR dose being delivered using the PVB technique. A failure will be defined as a patient who fails to use the method for any part of the treatment. In the event of a failure, both investigator and patient will be asked to specify the reason for failure for purposes of failure analysis.
次要结局
- Additional time-related endpoints for duration of breathhold with Percussive Ventilation (PV) breathhold intervention for Healthy patients(3 months)
- Exploratory clinical and dosimetric data on Percussive Ventilation Breathhold Stereotactic Ablative Radiotherapy (PVB SABR) technique(3 months)
- Additional time-related endpoints for duration of breathhold with Percussive Ventilation (PV) breathhold intervention for Healthy patients(Day 1 (during mock simulation visit for Arm 1 and simulation visit for Arm 2))
- Exploratory clinical and dosimetric data on PVB and PVB-SABR technique(Perioperative/Periprocedural)
研究者
Wilson Xuan Mai
Resident in Radiation Oncology - Radiation Therapy
Stanford University