Xenon-enhanced Ventilation CT-guided Radiotherapy for Lung Cancer Treatment
Primary Purpose
Lung Cancer, Radiation Therapy Complication
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Xenon-enhanced Ventilation CT-guided Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring lung cancer, Radiation Therapy, Xenon-enhanced ventilation CT
Eligibility Criteria
Inclusion Criteria:
- Patients aged 20-80 years, with lung cancer receiving thoracic radiotherapy in NTUH, from February 2020 to December 2024.
Exclusion Criteria:
- The age is less than 20 years old or older than 80 years old.
- Unstable clinical condition, unable to maintain apnea for 15 second, and history of prior adverse reaction to xenon.
- Renal insufficiency patients.
- Claustrophobia
- Those who are pregnant.
Sites / Locations
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Xenon-enhanced Ventilation CT-guided Radiotherapy
Arm Description
Patients will be receiving Xenon-enhanced Ventilation CT-guided Radiotherapy for functional lung avoidance. The doses for the tumors, lungs, and organs at risk will be examined and evaluated.
Outcomes
Primary Outcome Measures
Incidence of radiation pneumonia
Incidence of radiation pneumonia
Secondary Outcome Measures
Full Information
NCT ID
NCT05134558
First Posted
September 22, 2021
Last Updated
November 14, 2021
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05134558
Brief Title
Xenon-enhanced Ventilation CT-guided Radiotherapy for Lung Cancer Treatment
Official Title
Xenon-enhanced Ventilation CT-guided Radiotherapy for Lung Cancer Treatment: Functional Protection of the Lung and Prevention of Radiation Pneumonitis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 4, 2020 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators aim to use xenon-enhanced ventilation computed tomography (CT) to design personalized functional lung avoidance radiotherapy for lung cancer patients who are scheduled to receive lung radiation therapy. The investigators' goal is to optimally protect the lung function of the patients and reduce the incidence of radiation pneumonitis.
Detailed Description
There has been an increase in the application of radiation therapy in the treatment of lung tumors; however, the associated side effect, called radiation pneumonitis, can significantly reduce lung function and the quality of life of patients, eventually leading to fatal consequences. The investigators aim to use xenon-enhanced ventilation computed tomography (CT) to design personalized functional lung avoidance radiotherapy for lung cancer patients who are scheduled to receive lung radiation therapy. The investigators' goal is to optimally protect the lung function of the patients and reduce the incidence of radiation pneumonitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Radiation Therapy Complication
Keywords
lung cancer, Radiation Therapy, Xenon-enhanced ventilation CT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Xenon-enhanced Ventilation CT-guided Radiotherapy
Arm Type
Experimental
Arm Description
Patients will be receiving Xenon-enhanced Ventilation CT-guided Radiotherapy for functional lung avoidance. The doses for the tumors, lungs, and organs at risk will be examined and evaluated.
Intervention Type
Radiation
Intervention Name(s)
Xenon-enhanced Ventilation CT-guided Radiotherapy
Intervention Description
Xenon-enhanced Ventilation CT-guided Radiotherapy for functional protection of the lung
Primary Outcome Measure Information:
Title
Incidence of radiation pneumonia
Description
Incidence of radiation pneumonia
Time Frame
Within 1 year of radiation therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 20-80 years, with lung cancer receiving thoracic radiotherapy in NTUH, from February 2020 to December 2024.
Exclusion Criteria:
The age is less than 20 years old or older than 80 years old.
Unstable clinical condition, unable to maintain apnea for 15 second, and history of prior adverse reaction to xenon.
Renal insufficiency patients.
Claustrophobia
Those who are pregnant.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-Sen Huang, Md PhD
Phone
+886-23123456
Email
yusen0814@gmail.com
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu-Sen Huang, MD PhD
Phone
+886-23123456
Email
yusen0814@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Xenon-enhanced Ventilation CT-guided Radiotherapy for Lung Cancer Treatment
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