Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05283564
Other study ID # IRB-63842
Secondary ID NCI-2023-00704
Status Recruiting
Phase N/A
First received
Last updated
Start date November 2, 2022
Est. completion date May 4, 2025

Study information

Verified date May 2024
Source Stanford University
Contact Kelly Huang
Phone 650-724-4606
Email kelhuang@stanford.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date May 4, 2025
Est. primary completion date May 4, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Women. All women 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, women 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Percussive Ventilation Breathhold SABR (PVB-SABR)
Number of lung cancer patients with successful administration of PVB technique in PVB-SABR treatment

Locations

Country Name City State
United States Stanford Cancer Institute Palo Alto California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of successful Percussive Ventilation Breathhold (PVB) maneuver in healthy volunteers. The rate will be measured as the proportion of healthy volunteers who can be successfully execute the Percussive Ventilation Breathhold for 5 minutes. In the event of a failure, both investigator and patient will be asked to specify the reason for failure for purposes of failure analysis. 18 months
Primary Rate of successful administration of Percussive Ventilation Breathhold Stereotactic Ablative Radiotherapy (PVB SABR) in lung patients. The rate will be measured as the proportion of lung cancer patients who successfully complete treatment using the PVB SABR method as defined by 100% of the prescribed Stereotactic Ablative Radiotherapy dose being delivered using the Percussive Ventilation Breathhold (PVB) technique. A failure will be defined as a patient who fails to use the method for any part of the treatment. In the event of a failure, both investigator and patient will be asked to specify the reason for failure for purposes of failure analysis. 18 months
Secondary Additional time-related endpoints for duration of breathhold with Percussive Ventilation (PV) breathhold intervention for Healthy patients The rates will be measured as the proportion of healthy volunteers who can be successfully execute the PV breathhold for 10 minutes 3 months
Secondary Exploratory clinical and dosimetric data on Percussive Ventilation Breathhold Stereotactic Ablative Radiotherapy (PVB SABR) technique We will collect optional exploratory noninvasive clinical data during PVB including but not limited to real-time CO2 and SpO2 data (using the SenTec Digital Monitoring System or similar device) and surface anatomy monitoring (using devices such as Kinect camera, vision-RT, or laser surface monitoring system). All of these data will be collected on an optional exploratory basis. 3 months
See also
  Status Clinical Trial Phase
Completed NCT03918538 - A Series of Study in Testing Efficacy of Pulmonary Rehabilitation Interventions in Lung Cancer Survivors N/A
Recruiting NCT05078918 - Comprehensive Care Program for Their Return to Normal Life Among Lung Cancer Survivors N/A
Active, not recruiting NCT04548830 - Safety of Lung Cryobiopsy in People With Cancer Phase 2
Completed NCT04633850 - Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT05583916 - Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery N/A
Completed NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Not yet recruiting NCT06376253 - A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers Phase 1
Recruiting NCT05898594 - Lung Cancer Screening in High-risk Black Women N/A
Active, not recruiting NCT05060432 - Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Active, not recruiting NCT03575793 - A Phase I/II Study of Nivolumab, Ipilimumab and Plinabulin in Patients With Recurrent Small Cell Lung Cancer Phase 1/Phase 2
Terminated NCT01624090 - Mithramycin for Lung, Esophagus, and Other Chest Cancers Phase 2
Terminated NCT03275688 - NanoSpectrometer Biomarker Discovery and Confirmation Study
Not yet recruiting NCT04931420 - Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels Phase 2
Recruiting NCT06052449 - Assessing Social Determinants of Health to Increase Cancer Screening N/A
Recruiting NCT06010862 - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors Phase 1
Not yet recruiting NCT06017271 - Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer
Recruiting NCT05787522 - Efficacy and Safety of AI-assisted Radiotherapy Contouring Software for Thoracic Organs at Risk