RecruitingNot ApplicableNCT05283564

Study to Evaluate Percussive Ventilation Breathhold to Improve Lung Stereotactic Ablative Radiotherapy

A Pilot Study to Evaluate Percussive Ventilation Breathhold to Improve Lung Stereotactic Ablative Radiotherapy (PVB-SABR)


Sponsor

Stanford University

Enrollment

20 participants

Start Date

Nov 2, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria5

  • 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

Interventions

OTHERPercussive Ventilation Breathhold SABR (PVB-SABR)

Number of lung cancer patients with successful administration of PVB technique in PVB-SABR treatment


Locations(1)

Stanford Cancer Institute

Palo Alto, California, United States

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NCT05283564


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