Lung Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERPercussive Ventilation Breathhold SABR (PVB-SABR)
Number of lung cancer patients with successful administration of PVB technique in PVB-SABR treatment
Sponsors
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of successful Percussive Ventilation (PV) breathhold maneuver in healthy volunteers. | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | The rates will be measured as the proportion of healthy volunteers who can be successfully execute the PV breathhold for 10 minutes (Arm 1), as well as the proportion of patients who can execute a PV breathhold for both 5 and 10 minutes (Arm 2). |
| Exploratory clinical and dosimetric data on PVB and PVB-SABR technique | Perioperative/Periprocedural | For Arm 1, during treatment planning, radiation plans will be generated using conventional SABR techniques as well as with PVB technique which will enable collection of exploratory dosimetric data such as tumor volume treated, volume and dose to healthy lung irradiated, dose to nearby normal structures and related measures, as well as the reproducibility of sequential breathholds. For both arms, we will collect optional exploratory noninvasive clinical data during PVB including but not limited to real-time CO2 and SpO2 data (using the SenTec Digital Monitoring System or similar device) and surface anatomy monitoring (using devices such as Kinect camera, vision-RT, or laser surface monitoring system). All of these data will be collected on an optional exploratory basis. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORWilson X Mai, MD, PhD
Stanford University
Outcome results
None listed