NCT07339644Recruiting
Functional Lung Avoidance Radiotherapy Guided by 4DCT Pulmonary Ventilation Function Imaging: A Prospective Single-arm Clinical Study
Source: ClinicalTrials.gov · Last updated 9 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 5 Jan 2026
- Start date
- 24 Oct 2025
- Primary completion date
- 24 Dec 2026
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Diseases
- Lung cancer
- NCT number
- NCT07339644
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 24 Oct 2025 to the primary completion date, 24 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pregnant or breastfeeding women. Women of childbearing potential must have pregnancy excluded prior to radiotherapy per institutional practice.
- 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.
Other illness
- 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).
- Severe psychiatric, cognitive, or other conditions that prevent cooperation with radiotherapy and/or scheduled follow-up.
- Any other condition deemed unsuitable by the investigators in the interest of participant safety.
Age
- Age \<18 or \>85 years.
Other
- Inadequate 4DCT image quality or inability to generate/validate the 4DCT ventilation map required for functional-lung-guided planning.
Who the study is looking for
- 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.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Center, Second Affiliated Hospital of Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.