4DCT-guided functional lung avoidance radiotherapy to spare high-function lung
Functional Lung Avoidance Radiotherapy Guided by 4DCT Pulmonary Ventilation Function Imaging: A Prospective Single-arm Clinical Study
This study will test whether using 4DCT-derived lung ventilation maps to guide radiotherapy can better spare high-function lung in adults receiving thoracic IMRT or SBRT for lung cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | The Second Affiliated Hospital of Chongqing Medical University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Chongqing) |
| Trial ID | NCT07339644 on ClinicalTrials.gov |
What this trial studies
This single-center, prospective single-arm study will enroll adults with lung malignancies scheduled for thoracic IMRT/VMAT or SBRT. All participants undergo 4DCT simulation to generate a ventilation map; the top 80% ventilation region is defined as the high-function lung and imported into the treatment planning system to create a functional lung avoidance radiotherapy (FLAR) plan. A conventional anatomic plan without functional guidance will also be created for paired, within-patient dosimetric comparison while maintaining PTV D95% and standard organ-at-risk constraints. The primary outcome is improved dosimetric sparing of the high-function lung (V10, V20, V30, and mean lung dose), with secondary outcomes including incidence of radiation pneumonitis, radiation-induced lung injury, and overall treatment safety.
Who should consider this trial
Good fit: Adults aged 18–85 with lung malignancies who are planned for thoracic IMRT/VMAT or SBRT, have ECOG performance status 0–1, and can complete a pre-treatment 4DCT simulation to generate ventilation maps are ideal candidates.
Not a fit: Patients who cannot tolerate or complete 4DCT, have poor performance status, diffuse bilateral lung involvement, or prior high-dose thoracic irradiation are unlikely to receive meaningful benefit.
Why it matters
Potential benefit: If successful, this approach could reduce radiation dose to the most functional lung tissue and potentially lower rates of radiation pneumonitis and other lung injury.
How similar studies have performed: Prior dosimetric and early clinical studies using 4DCT or other functional imaging for lung-sparing radiotherapy have shown improved dose sparing of high-function lung, but clear evidence that this reduces clinical pneumonitis or improves long-term outcomes remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Chongqing
- Cancer Center, Second Affiliated Hospital of Chongqing Medical University — Chongqing, China (Recruiting)
Study contacts
- Principal investigator: zhengjun Guo, MD. — The Second Clinical College of Chongqing Medical University: The Second Affiliated Hospital of Chongqing Medical University
- Study coordinator: Zhi chen, MD.
- Email: 2023440076@stu.cqmu.edu.cn
- Phone: +86 18982928222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.