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NCT05283564 | RECRUITING | Lung Cancer

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

Stanford University

Brief 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.

Condition or disease

Lung Cancer

Intervention/treatment

Percussive Ventilation Breathhold SABR (PVB-SABR)

Phase

NA

Detailed Description:

Primary Objective(s) * To determine the rate of successful administration of the PVB-SABR in lung cancer patients. * To determine the rate of successful administration of PVB in healthy volunteers for 5 minutes Secondary Objective(s) * To determine the rate of successful administration of PVB in healthy volunteers for 10 minutes as well as for patients' successfully completing the technique for 5 and 10 minutes. * To collect exploratory clinical (both arms) and dosimetric data from lung cancer patients using PVB-SABR.

Study Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : A Pilot Study to Evaluate Percussive Ventilation Breathhold to Improve Lung Stereotactic Ablative Radiotherapy (PVB-SABR)
Actual Study Start Date : 2022-11-02
Estimated Primary Completion Date : 2026-05-04
Estimated Study Completion Date : 2026-09-04

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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
Study to Evaluate Percussive Ventilation Breathhold to Improve Lung Stereotactic Ablative Radiotherapy

Location Details

NCT05283564

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Locations

RECRUITING

United States, California

Stanford Cancer Institute

Palo Alto, California, United States, 94305