💬In plain words
What the trial is, and whether it could suit you
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
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📋 Eligibility rules (as published)
Inclusion Criteria:
* Age 18 to 85 years (inclusive); any sex.
* Diagnosed lung malignancy requiring thoracic radiotherapy (e.g., non-small cell lung cancer, small cell lung cancer, or pulmonary metastases).
* Planned to receive thoracic radiotherapy using either conventionally fractionated IMRT/VMAT or stereotactic body radiotherapy (SBRT), and able to complete pre-treatment 4DCT simulation suitable for generating a ventilation map.
* Adequate baseline organ function and clinically judged able to tolerate radiotherapy; ECOG performance status 0-1.
* No absolute contraindication to pulmonary function testing; patients with moderate COPD or impaired lung function may be included if the treating team judges radiotherapy to be tolerable.
* Able to comply with treatment and follow-up assessments.
* Written informed consent provided.
Exclusion Criteria:
* Pregnant or breastfeeding women. Women of childbearing potential must have pregnancy excluded prior to radiotherapy per institutional practice.
* Age \<18 or \>85 years.
* Uncontrolled severe cardiopulmonary disease or other severe comorbidities that make radiotherapy excessively high risk (e.g., decompensated heart failure, unstable cardiopulmonary status, active severe pulmonary infection).
* Prior high-dose thoracic radiotherapy to the same region such that safe re-irradiation is not feasible.
* Concurrent other active/advanced malignancy requiring priority treatment that would confound study outcomes.
* Recent participation in another interventional clinical trial or concurrent investigational therapy judged likely to interfere with this study's endpoints.
* Severe psychiatric, cognitive, or other conditions that prevent cooperation with radiotherapy and/or scheduled follow-up.
* Inadequate 4DCT image quality or inability to generate/validate the 4DCT ventilation map required for functional-lung-guided planning.
* Any other condition deemed unsuitable by the investigators in the interest of participant safety.
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