RecruitingNot ApplicableNCT07339644

Functional Lung Avoidance Radiotherapy Guided by 4DCT Pulmonary Ventilation Function Imaging: A Prospective Single-arm Clinical Study

Sponsor

The Second Affiliated Hospital of Chongqing Medical University

Enrollment

100 participants

Start Date

Oct 24, 2025

Study Type

INTERVENTIONAL

Conditions

Radiation Pneumonitis Lung Cancer (Including Metastatic Cancer)

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a technique called functional lung avoidance radiotherapy, where a specialised lung scan (4DCT ventilation imaging) is used to map the parts of the lung that are working best — and then radiation is directed away from those areas to protect breathing function during treatment. **You may be eligible if...** - You are 18–85 years old - You have a lung cancer or a lung tumour that requires radiation therapy - You are planned for standard or stereotactic radiation to the chest - You are in good health (ECOG 0–1) with adequate organ function - You do not have an absolute contraindication to lung function testing **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have severe uncontrolled heart or lung disease (e.g., decompensated heart failure) - You have already received high-dose radiation to the same area of the chest - You have another active cancer requiring priority treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURE4DCT Ventilation Imaging-Guided Functional Lung Avoidance Radiotherapy (FLAR)

All participants undergo 4DCT simulation. A ventilation map is generated from 4DCT data, and the high-function lung is defined as the top 80% ventilation region. This structure is imported into the treatment planning system, and an IMRT plan is optimized to preferentially spare high-function lung while maintaining target (PTV) coverage and meeting standard organ-at-risk constraints. A conventional anatomic plan (without functional guidance) is also created for within-patient paired dosimetric comparison.