Evaluating a new breathing technique to improve lung cancer radiotherapy
A Pilot Study to Evaluate Percussive Ventilation Breathhold to Improve Lung Stereotactic Ablative Radiotherapy (PVB-SABR)
This study is testing a new breathing technique to see if it can help improve radiation treatment for people with lung cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT05283564 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of Percussive Ventilation Breathhold (PVB) in enhancing the accuracy of stereotactic ablative radiotherapy (SABR) for lung cancer patients. The primary objective is to determine the success rate of administering PVB in both lung cancer patients and healthy volunteers. Secondary objectives include evaluating the administration success for varying durations and collecting clinical and dosimetric data from participants. The study involves both healthy individuals and patients diagnosed with lung cancer, focusing on their ability to complete the PVB technique.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 or older with a diagnosis of primary lung cancer or lung metastases, as well as healthy volunteers.
Not a fit: Patients who are pregnant or have an ECOG Performance Status greater than 3 may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more precise radiotherapy treatments for lung cancer, potentially improving patient outcomes.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving radiotherapy techniques, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Palo Alto, California
- Stanford Cancer Institute — Palo Alto, California, United States (Recruiting)
Study contacts
- Principal investigator: Wilson X Mai, MD, PhD — Stanford University
- Study coordinator: Kelly Huang
- Email: kelhuang@stanford.edu
- Phone: 650-724-4606
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.