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Functional lung avoidance radiotherapy guided by 4DCT pulmonary ventilation function imaging: A prospective single-arm clinical study

Functional lung avoidance radiotherapy guided by 4DCT pulmonary ventilation function imaging: A prospective single-arm clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111036
Enrollment
Unknown
Registered
2025-10-24
Start date
2025-10-24
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant tumor of the lung

Interventions

Experimental Group:Functional lung avoids radiotherapy

Sponsors

The Second Affiliated Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >= 18 years, any gender; 2.Pathologically confirmed malignant pulmonary tumor (non-small cell lung cancer, small cell lung cancer, or pulmonary metastases) requiring thoracic radiotherapy; 3.Planned to receive standard thoracic radiotherapy and able to complete routine pre-treatment 4DCT simulation (prescribed dose >= 45 Gy); 4.Adequate organ function to tolerate radiotherapy; ECOG performance status 0–1; 5.No absolute contraindications to pulmonary function (e.g., patients with moderate COPD may be included if clinically assessed to tolerate radiotherapy); 6.Signed informed consent form and voluntary participation;

Exclusion criteria

Exclusion criteria: 1.Special populations: pregnant or breastfeeding women; minors under 18 years of age. Due to the potential harm of radiation to a fetus or infant, women of childbearing potential must have pregnancy excluded before enrollment. 2.Disease conditions: early-stage lung cancer patients planned for stereotactic body radiotherapy (SBRT) (small treatment field and good prognosis, minimal value in functional avoidance); patients with other advanced malignancies requiring priority treatment. 3.Prior treatment history: previous high-dose chest radiotherapy to the same region resulting in lung tolerance near its maximum limit (unsafe for re-irradiation); participation in other interventional clinical trials in the recent past that could interfere with this study’s results. 4.Severe comorbidities: uncontrolled serious cardiopulmonary disease (e.g., decompensated heart failure, active severe pulmonary infection) rendering radiotherapy excessively risky; psychiatric or cognitive disorders preventing compliance with treatment or follow-up. 5.Other circumstances deemed unsuitable for participation by the investigators. Borderline cases will be carefully reviewed by the study team to ensure participant safety.

Design outcomes

Primary

MeasureTime frame
The dosimetric improvement ranges of V10, V20, V30, MLD, etc. in the high-function lung area;

Secondary

MeasureTime frame
Incidence of grade 2 radiation pneumonitis (CTCAE v5.0);FEV? /DLCO variation;Quality of life (lung function-related) score;

Countries

China

Contacts

Public ContactZhengzhou Yang

The Second Affiliated Hospital of Chongqing Medical University

yangzhenzhou@sohu.com+86 13883270881

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026