- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05134558
Xenon-enhanced Ventilation CT-guided Radiotherapy for Lung Cancer Treatment
November 14, 2021 updated by: National Taiwan University Hospital
Xenon-enhanced Ventilation CT-guided Radiotherapy for Lung Cancer Treatment: Functional Protection of the Lung and Prevention of Radiation Pneumonitis
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yu-Sen Huang, MD PhD
- Phone Number: +886-23123456
- Email: yusen0814@gmail.com
Study Locations
-
-
-
Taipei, Taiwan, 100
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Yu-Sen Huang, MD PhD
- Phone Number: +886-23123456
- Email: yusen0814@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Xenon-enhanced Ventilation CT-guided Radiotherapy
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.
|
Xenon-enhanced Ventilation CT-guided Radiotherapy for functional protection of the lung
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of radiation pneumonia
Time Frame: Within 1 year of radiation therapy
|
Incidence of radiation pneumonia
|
Within 1 year of radiation therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 4, 2020
Primary Completion (Anticipated)
December 31, 2024
Study Completion (Anticipated)
December 31, 2024
Study Registration Dates
First Submitted
September 22, 2021
First Submitted That Met QC Criteria
November 14, 2021
First Posted (Actual)
November 26, 2021
Study Record Updates
Last Update Posted (Actual)
November 26, 2021
Last Update Submitted That Met QC Criteria
November 14, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201912128RIN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.