Use of 4-dimensional computed tomography-based ventilation imaging to correlate lung dose and function with clinical outcomes.
Yevgeniy Vinogradskiy, Richard Castillo, Edward Castillo...
https://pubmed.ncbi.nlm.nih.gov/23474113Actively Recruiting
Phase Not Applicable
Age: 18Years - 85Years
All Genders
ID07339644
Functional Lung Avoidance Radiotherapy Guided by 4DCT Pulmonary Ventilation Function Imaging: A Prospective Single-arm Clinical Study
Led by The Second Affiliated Hospital of Chongqing Medical University · Updated on 2026-02-09
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility and safety of a new type of radiotherapy called 4DCT ventilation functional imaging-guided functional lung avoidance radiotherapy (FLAR) in patients with lung cancers. This study focuses on patients who require intensity-modulated radiation therapy (IMRT) for thoracic tumors and aims to reduce damage to the high-functioning areas of the lung while maintaining effective treatment of the cancer. The trial is a prospective, single-center, single-arm study designed to compare this new planning method with conventional anatomic radiotherapy planning within the same patients. All participants will undergo a 4DCT scan before starting radiotherapy to create a ventilation map of their lungs. The top 80% of lung regions with the highest ventilation will be identified as "high-function lung." Using this information, the treatment plan is optimized to spare these critical lung areas while ensuring the cancer target receives adequate radiation. In addition to the FLAR plan, a traditional radiotherapy plan will also be created for comparison but will not be used for treatment. The study uses IMRT for delivering radiation, and treatment planning is carefully adjusted to meet standard dose limits for organs at risk. Participants will be assessed at multiple points: mid-treatment (after 15 radiation fractions), at the end of treatment (after 30 fractions), and during follow-up visits at 1, 3, 6, and 12 months after radiotherapy. Researchers will monitor lung function tests such as forced expiratory volume in 1 second (FEV1) and diffusing capacity of the lung for carbon monoxide (DLCO), check for radiation-induced lung injury (pneumonitis), and evaluate quality of life related to lung health. Each participant will be followed for one year after treatment to evaluate safety and lung function changes associated with the new radiotherapy planning method.
CONDITIONS
Brief Title
Functional Lung Avoidance Radiotherapy Guided by 4DCT Pulmonary Ventilation Function Imaging: A Prospective Single-arm Clinical Study
Who Can Participate
Age: 18Years - 85Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 to 85 years (inclusive); any sex.
- Diagnosed lung malignancy requiring thoracic radiotherapy such as non-small cell lung cancer, small cell lung cancer, or pulmonary metastases.
- Planned to receive thoracic radiotherapy using IMRT, VMAT, or stereotactic body radiotherapy (SBRT).
- Able to complete pre-treatment 4DCT simulation suitable for ventilation mapping.
- Adequate baseline organ function and ECOG performance status of 0-1.
- No absolute contraindications to pulmonary function testing; moderate COPD or impaired lung function allowed if radiotherapy is tolerable.
- Able to comply with treatment and follow-up assessments.
- Provided written informed consent.
You will not qualify if you...
- Pregnant or breastfeeding women; pregnancy must be excluded before radiotherapy.
- Age under 18 or over 85 years.
- Uncontrolled severe cardiopulmonary disease or other severe comorbidities making radiotherapy too risky.
- Prior high-dose thoracic radiotherapy to the same area preventing safe re-irradiation.
- Concurrent active advanced malignancy requiring other priority treatment.
- Recent participation in another interventional trial or concurrent investigational therapy interfering with study outcomes.
- Severe psychiatric, cognitive, or other conditions preventing cooperation with radiotherapy or follow-up.
- Inadequate 4DCT image quality or inability to generate required ventilation map.
- Any other safety concerns as judged by investigators.
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Duration of radiotherapy treatment period
Participants receive intensity-modulated radiotherapy (IMRT) planned with 4DCT ventilation functional imaging guidance to spare high-function lung while maintaining target coverage and meeting standard organ-at-risk constraints.
Multiple visits during radiotherapy delivery
Follow-up
Duration - Up to 12 months after radiotherapy completion
Participants are monitored with lung function tests and assessments for radiation-induced lung injury at several time points after treatment completion.
Visits at 1, 3, 6, and 12 months after treatment
Trial Site Locations
Total: 1 location
1
Cancer Center, Second Affiliated Hospital of Chongqing Medical University
Chongqing, China, 400000
Actively Recruiting
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Research Team
Z
Zhi chen, MD.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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