PVB-SABR for Lung Cancer

Overseen By Anoushka Kathiravan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Pregnancy, Severe pulmonary fibrosis, Pneumothorax, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 18 months

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively Percussive Ventilation Breathhold (PVB) can enhance the precision of radiotherapy for lung tumors. It involves two groups: lung cancer patients using PVB during treatment and healthy volunteers practicing the PVB technique. Potential participants include lung cancer patients who are candidates for a specific type of radiotherapy and are willing to sign a consent form. As an unphased study, this trial allows participants to contribute to innovative research that could improve future cancer treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What prior data suggests that the Percussive ventilation breathhold (PVB) technique is safe?

Research shows that Percussive Ventilation Breathhold (PVB) is under study to enhance the precision of radiotherapy for lung cancer. This technique involves holding the breath to help target the tumor more accurately. Studies suggest that similar methods have been well-tolerated, but specific information about PVB's safety in humans is still being gathered.

The trial aims to assess how well participants can perform this breathhold technique. While specific data on PVB's side effects is not yet available, breathhold techniques in general have not shown serious side effects in other contexts. However, since this trial is in the early stages, the main focus is on understanding the method's safety and practicality.

Prospective participants should discuss any concerns with the research team. They can provide more details on what to expect and any possible risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PVB-SABR technique for lung cancer because it introduces a novel approach to precision radiation therapy. Unlike traditional methods, which might not account for a patient's breathing, this technique incorporates a percussive ventilation breathhold, potentially leading to more accurate targeting of the tumor. This could mean less damage to surrounding healthy tissue and more effective treatment outcomes. By using a verification cone-beam CT scan during the breathhold, the method ensures precise delivery of radiation, which is a significant advancement over existing treatments.

What evidence suggests that the PVB-SABR technique is effective for lung cancer?

Studies have shown that Stereotactic Ablative Radiotherapy (SABR) is a promising treatment for early-stage non-small cell lung cancer. It can be more effective than regular radiotherapy because it delivers high doses of radiation to a specific area, potentially leading to better outcomes. This trial tests the Percussive Ventilation Breathhold (PVB) technique to determine if it can enhance SABR's accuracy by improving patients' breath-holding during treatment. This could reduce tumor movement, allowing for more precise targeting. Early research suggests that breath-holding techniques might improve radiotherapy accuracy, potentially leading to better treatment results. ^{6 7 8 9 10}

Who Is on the Research Team?

Wilson X Mai, MD, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with lung cancer or cancer that has spread to my lungs.

I can do some activities but not work, or I'm mostly in bed but can be up.

I am considered fit for standard lung cancer radiation treatment.

Exclusion Criteria

No Pregnant Women

I have recently developed a collapsed lung.

I am not a candidate for standard lung SABR due to my condition or tumor size.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Percussive Ventilation Breathhold Stereotactic Ablative Radiotherapy (PVB-SABR) for lung cancer treatment

18 months

Regular visits for treatment and monitoring

Exploratory Data Collection

Collection of optional exploratory clinical and dosimetric data during PVB

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Percussive Ventilation Breathhold SABR (PVB-SABR)

Trial Overview 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.

How Is the Trial Designed?

Group I: Administration of the PVB-SABR in lung cancer patients Experimental Treatment 1 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 volunteers Experimental Treatment 1 Intervention

The healthy patient will execute the Percussive ventilation breathhold technique

Percussive Ventilation Breathhold SABR (PVB-SABR) is already approved in European Union, United States, United Kingdom for the following indications:

Approved in European Union as SABR for:

• Primary lung cancer
• Liver cancer
• Pancreatic cancer
• Prostate cancer
• Brain metastases

Approved in United States as SABR for:

• Primary lung cancer
• Liver cancer
• Pancreatic cancer
• Prostate cancer
• Brain metastases

Approved in United Kingdom as SABR for:

• Primary lung cancer
• Liver cancer
• Pancreatic cancer
• Prostate cancer
• Brain metastases

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

Stereotactic ablative body radiotherapy (SABR) is a significant advancement in radiotherapy that has been shown to improve tumor control and overall survival in patients with lung tumors.

The review highlights the current evidence supporting the efficacy of SABR for both primary and secondary lung tumors, along with ongoing trials that may further validate its benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy (SABR) for primary and secondary lung tumours. Goldsmith, C., Gaya, A.[2022]

Stereotactic ablative body radiotherapy (SABR) is now the standard treatment for early-stage non-small-cell lung cancer (NSCLC) in patients who cannot undergo surgery, highlighting its efficacy in this patient population.

The review also discusses the safety profile of SABR, including reported toxicity rates, and explores its potential use in combination with other therapies for improved outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of outcomes following stereotactic ablative radiotherapy in the treatment of early-stage primary lung cancer. Murray, P., Franks, K., Hanna, GG.[2022]

Stereotactic ablative radiotherapy (SABR) is an effective treatment for early-stage non-small cell lung cancers (NSCLCs) that are medically inoperable, providing local control and toxicity levels comparable to surgical resection.

SABR is gaining interest as a noninvasive treatment option for patients with borderline resectable lung cancers, although further randomized studies are needed to evaluate its survival benefits in operable patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy (SABR) for non-small cell lung cancer. Iyengar, P., Westover, K., Timmerman, RD.[2013]

Stereotactic ablative radiation therapy (SABR) was found to be effective for treating pulmonary metastases, with a median follow-up of 23 months showing improved overall survival (OS) for patients with 3 or fewer metastases compared to those with more (74.2% vs. 59.3% at 24 months).

Patients with less responsive primary tumors (like adrenal or pancreatic cancers) had higher local failure rates, suggesting that higher doses of SABR or surgical options may be necessary for these cases to improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiation therapy for pulmonary metastases: Improving overall survival and identifying subgroups at high risk of local failure. Pasalic, D., Lu, Y., Betancourt-Cuellar, SL., et al.[2021]

In a multicenter phase 3 trial involving 101 patients with inoperable stage 1 non-small-cell lung cancer, stereotactic ablative body radiotherapy (SABR) demonstrated significantly better local control compared to standard radiotherapy, with a 68% reduction in the risk of local treatment failure (hazard ratio 0.32).

SABR was associated with a similar safety profile to standard radiotherapy, showing no increase in major toxicity, making it a preferred treatment option for patients with this type of lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy versus standard radiotherapy in stage 1 non-small-cell lung cancer (TROG 09.02 CHISEL): a phase 3, open-label, randomised controlled trial. Ball, D., Mai, GT., Vinod, S., et al.[2022]

In a study of 100 patients with early-stage non-small cell lung cancer (NSCLC) treated with stereotactic ablative body radiotherapy (SABR), the 1-, 2-, and 3-year local control rates were 100%, 93.55%, and 84.33%, respectively, indicating high efficacy in tumor control.

The treatment was associated with low toxicity, with only 2% of patients experiencing Grade-3 side effects, suggesting that SABR is a safe option for patients who are inoperable or refuse surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Definitive Treatment of Early-Stage Non-Small Cell Lung Cancer with Stereotactic Ablative Body Radiotherapy in a Community Cancer Center Setting. Heal, C., Ding, W., Lamond, J., et al.[2020]

Citations

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Study to Evaluate Percussive Ventilation Breathhold to ... The purpose of this research is to evaluate and determine the rate of successful administration of Percussive ventilation breathhold (PVB) to allow for more ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6043889/

A Population-based Study of the Effectiveness of Stereotactic ... Stereotactic ablative radiotherapy (SABR) is a promising option for non-operated early-stage non-small cell lung cancer (NSCLC) compared to conventional ...

3. app.trialscreen.org app.trialscreen.org/trials/lung-cancer-to-evaluate-percussive-ventilation-breathhold-improve-stereotactic-trial-nct05283564

Study to Evaluate Percussive Ventilation Breathhold ... Participation in this study may help improve the precision and effectiveness of radiotherapy treatment for lung cancer by evaluating a new breathing technique ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S036030161500632X

Continuous Positive Airway Pressure for Motion ... We hypothesized that the use of CPAP would reduce tumor and organ motion by decreasing diaphragm motion and tidal volume and would also create favorable ...

5. advancesradonc.org advancesradonc.org/article/S2452-1094(24)00242-2/pdf

Noninvasive Mechanical Ventilation Is a Promising Way to ... NIMV at 30 brpm in 5 patients with lung cancer resulted in decreased tumor motion in 3 patients, but increased motion in 2 patients.15 ...

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Eligibility - Stanford Medicine The purpose of this research is to evaluate and determine the rate of successful administration of Percussive ventilation breathhold (PVB) to allow for more ...

7. redjournal.org redjournal.org/issue/S0360-3016(25)X0009-2?pageStart=17

September 01, 2025 A Pilot Study to Evaluate Percussive Ventilation Breath Hold to Improve Lung Stereotactic Ablative Radiotherapy (PVB-SABR). W.X. Mai,; K.Z. Huang,; S. Wong ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35600391/

Safety and Efficacy of Stereotactic Ablative Radiotherapy ... Patients with UCLC can benefit from SBRT at a dose of 56 Gy/6-8f. On the other hand, smaller PTV was associated with superior outcomes, ...

9. clinconnect.io clinconnect.io/trials/NCT05283564

Study to Evaluate Percussive Ventilation Breathhold to The goal is to see how well this technique works in making sure radiation is delivered precisely to lung tumors, which could lead to better treatment outcomes ...

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Proceedings of the American Radium Society ® 106th ... Background: Highly precise stereotactic ablative radiotherapy (SABR) has proven to be an effective curative option for early-stage lung cancer (Chang JY, et al.