Actively Recruiting
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
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This prospective, single-center, single-arm study will evaluate the feasibility and safety of 4DCT ventilation functional imaging-guided functional lung avoidance radiotherapy (FLAR) in patients with lung malignancies receiving IMRT radiotherapy. All participants will undergo 4DCT simulation as part of routine radiotherapy preparation. A ventilation map will be generated from 4DCT data, and the top 80% ventilation region will be defined as the high-function lung. This structure will be imported into the treatment planning system to create an FLAR plan that prioritizes sparing of high-function lung while maintaining target coverage (PTV D95%) and meeting standard dose constraints for organs at risk. A conventional anatomic plan (without functional guidance) will also be created for paired, within-patient dosimetric comparison. The primary outcome is improvement in dosimetric sparing of the high-function lung (V10, V20, V30, and mean lung dose). Secondary outcomes include the incidence of grade ≥2 radiation pneumonitis (CTCAE v5.0), changes in pulmonary function (e.g., FEV1 and DLCO), and lung-related quality-of-life scores. Assessments will be performed mid-treatment (after 15 fractions), at the end of radiotherapy (after 30 fractions), and at 1, 3, 6, and 12 months after radiotherapy. The study plans to enroll 100 participants and follow each participant for 12 months.
CONDITIONS
Official Title
Functional Lung Avoidance Radiotherapy Guided by 4DCT Pulmonary Ventilation Function Imaging: A Prospective Single-arm Clinical Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 85 years inclusive
- Diagnosed lung malignancy requiring thoracic radiotherapy (non-small cell lung cancer, small cell lung cancer, or pulmonary metastases)
- Planned thoracic radiotherapy using IMRT, VMAT, or stereotactic body radiotherapy (SBRT)
- Able to complete 4DCT simulation suitable for ventilation map generation
- Adequate baseline organ function and ECOG performance status 0-1
- No absolute contraindications to pulmonary function testing
- Able to tolerate radiotherapy as judged by treating team
- Able to comply with treatment and follow-up assessments
- Provided written informed consent
You will not qualify if you...
- Pregnant or breastfeeding women; women of childbearing potential must have pregnancy excluded before radiotherapy
- Age younger than 18 or older than 85 years
- Uncontrolled severe cardiopulmonary disease or other severe comorbidities making radiotherapy too risky
- Prior high-dose thoracic radiotherapy to the same region preventing safe re-irradiation
- Active other advanced malignancy requiring priority treatment that could affect study outcomes
- Recent participation in another interventional clinical trial or concurrent investigational therapy that may interfere with this study
- Severe psychiatric, cognitive, or other conditions preventing cooperation with radiotherapy or follow-up
- Inadequate 4DCT image quality or inability to generate/validate the ventilation map
- Any other condition deemed unsafe by investigators
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cancer Center, Second Affiliated Hospital of Chongqing Medical University
Chongqing, China, 400000
Actively Recruiting
Research Team
Z
Zhi chen, MD.
CONTACT
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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