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Radiation Therapy
PVB-SABR for Lung Cancer
N/A
Recruiting
Led By Wilson X Mai, MD, PhD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with a diagnosis of primary lung cancer or lung metastases of any primary tumor origin
Healthy volunteers age 18 or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
Study Summary
This trial is testing a new way to help people with lung cancer during radiation treatment.
Who is the study for?
This trial is for adults with primary lung cancer or lung metastases who are fit enough for standard radiotherapy. It's open to those with a performance status of up to 3 if doctors think it's safe. Pregnant women, patients with very large tumors, severe pulmonary fibrosis, recent pneumothorax, or critical illnesses like active infections can't participate.Check my eligibility
What is being tested?
The study is testing PVB-SABR—a technique using percussive ventilation during breathholds—to improve the precision of stereotactic ablative radiotherapy for treating lung tumors. The goal is to see how well patients can receive this treatment.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks may include discomfort from holding breath during treatment and potential complications related to precise targeting of radiation such as skin irritation or damage to nearby organs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with lung cancer or cancer that has spread to my lungs.
Select...
I am 18 or older and in good health.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of successful Percussive Ventilation Breathhold (PVB) maneuver in healthy volunteers.
Rate of successful administration of Percussive Ventilation Breathhold Stereotactic Ablative Radiotherapy (PVB SABR) in lung patients.
Secondary outcome measures
Additional time-related endpoints for duration of breathhold with Percussive Ventilation (PV) breathhold intervention for Healthy patients
Exploratory clinical and dosimetric data on Percussive Ventilation Breathhold Stereotactic Ablative Radiotherapy (PVB SABR) technique
Trial Design
2Treatment groups
Experimental Treatment
Group I: Administration of the PVB-SABR in lung cancer patientsExperimental Treatment1 Intervention
Lung cancer patients will execute a PV breathhold and a verification cone-beam CT scan.
Group II: Administration of Percussive ventilation breathhold (PVB) technique in healthy volunteersExperimental Treatment1 Intervention
The healthy patient will execute the Percussive ventilation breathhold technique
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,408 Previous Clinical Trials
17,343,432 Total Patients Enrolled
Wilson X Mai, MD, PhDPrincipal InvestigatorStanford University
Erik Blomain, MD, PHDPrincipal InvestigatorStanford University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with lung cancer or cancer that has spread to my lungs.I am 18 or older and in good health.I have recently developed a collapsed lung.I can do some activities but not work, or I'm mostly in bed but can be up.I am not a candidate for standard lung SABR due to my condition or tumor size.I am not critically ill with conditions like severe lung blood clots or infections needing hospital care.I am unable to walk or care for myself.I am considered fit for standard lung cancer radiation treatment.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Administration of the PVB-SABR in lung cancer patients
- Group 2: Administration of Percussive ventilation breathhold (PVB) technique in healthy volunteers
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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