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Radiation Therapy

PVB-SABR for Lung Cancer

N/A
Recruiting
Led By Erik Blomain, 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 during first education session (8 weeks), then at the time of mock simulation (3 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 below
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I have been diagnosed with lung cancer or cancer that has spread to my lungs.
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I am 18 or older and in good health.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during first education session (8 weeks), then at the time of mock simulation (3 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and during first education session (8 weeks), then at the time of mock simulation (3 months) for reporting.

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
Additional time-related endpoints for duration of breathhold with Percussive Ventilation Breathhold (PVB) intervention for lung cancer patients
Exploratory clinical and dosimetric data on Percussive Ventilation Breathhold (PVB)
+7 more

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

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,335 Total Patients Enrolled
Erik Blomain, MD, PHDPrincipal InvestigatorStanford University

Media Library

Percussive Ventilation Breathhold SABR (PVB-SABR) (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05283564 — N/A
Lung Cancer Research Study Groups: Administration of the PVB-SABR in lung cancer patients, Administration of Percussive ventilation breathhold (PVB) technique in healthy volunteers
Lung Cancer Clinical Trial 2023: Percussive Ventilation Breathhold SABR (PVB-SABR) Highlights & Side Effects. Trial Name: NCT05283564 — N/A
Percussive Ventilation Breathhold SABR (PVB-SABR) (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05283564 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment still enrolling participants?

"Affirmative. According to the clinicaltrials.gov website, this experiment is still recruiting patients who were initially posted on November 2nd 2022 and updated recently on that same day. For now, 20 people are needed from one medical site for the trial's completion."

Answered by AI

What key aims is this research trying to achieve?

"This medical trial, which is expected to run for 18 months, aims to evaluate the efficacy of PVB SABR in lung patients. Secondary objectives include collecting STAI patient anxiety data and estimating the proportion of participants who can last a full 5 or 10 minutes during Percussive Ventilation Breathholds both among cancerous and healthy individuals."

Answered by AI

How extensive is the scope of this experiment?

"Affirmative. Clinicaltrials.gov confirms that this clinical study, which was first advertised on November 2nd 2022, is actively searching for contributors. Approximately 20 participants need to be recruited from 1 facility."

Answered by AI
~0 spots leftby May 2024