Clinical trial · Observational
Application of 4DCT-Based Pulmonary Ventilation Imaging in Lung Cancer Radiotherapy
Clinical Study on 4DCT-Based Pulmonary Ventilation Imaging for Functional Lung Avoidance in Radiotherapy of Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This retrospective single-center study investigates whether four-dimensional CT (4DCT)-based lung ventilation imaging can guide functional lung avoidance radiotherapy (FLAR) for patients with primary lung cancer. Ventilation maps generated from planning 4DCT are used to identify well-ventilated lung regions, enabling paired comparison between functional lung avoidance radiotherapy plans and conventional anatomic radiotherapy plans. The study aims to assess whether incorporating functional lung information into radiotherapy planning can reduce radiation exposure to well-ventilated lung while maintaining adequate tumor coverage, and to explore its relationship with radiation-induced lung injury. All analyses are based on existing clinical imaging, treatment planning data, and follow-up records. No additional interventions, imaging, or procedures are performed as part of this study.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Radiation Pneumonitis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- 4DCT-IMRT Lung Cancer Cohort
- description
- Single-center retrospective cohort of consecutive lung cancer patients with high-quality 4DCT planned with IMRT (2022-01-01-2025-09-09; actual enrollment = 202). 4DCT-based ventilation maps delineate high-function lung. Paired-plan comparison of functional-lung-avoidance versus conventional plans; primary outcomes: dose to high-function lung and radiation pneumonitis. Secondary outcomes: doses to heart, spinal cord, and esophagus, and plan-quality metrics (e.g., MLD, V20, DVH). No additional procedures or treatments.
Primary outcomes (1)
- measure
- Incidence of Radiation-Induced Lung Injury (Grade ≥2)
- timeFrame
- Assessed at 3 months, 6 months, and 12 months after completion of radiotherapy.
- description
- Incidence of radiation-induced lung injury (RILI) of Grade ≥ 2, assessed using the Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0. CTCAE grades range from Grade 1 (mild) to Grade 5 (death related to adverse event), with higher grades indicating more severe toxicity. The primary outcome is the proportion of patients experiencing CTCAE Grade ≥ 2 RILI.
Secondary outcomes (10)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed primary lung cancer (adenocarcinoma, squamous cell carcinoma, or small-cell carcinoma) treated with thoracic radiotherapy. * High-quality 4DCT scans performed before radiotherapy, enabling generation of ventilation or perfusion maps. * Radiotherapy plans designed using IMRT. * Availability of both functional lung avoidance plans and conventional anatomical radiotherapy plans for paired analysis. * Complete treatment and follow-up records, including radiation-induced lung injury (e.g., radiation pneumonitis) and pulmonary function tests. Exclusion Criteria: * Incomplete or poor-quality imaging data preventing accurate ventilation/perfusion map generation. * Radiotherapy interrupted or incomplete for any reason. * Severe underlying lung diseases (e.g., extensive emphysema, pulmonary fibrosis, active tuberculosis) that may confound treatment outcomes or toxicity assessment. * Presence of other untreated primary malignancies during the study period. * Prior lung surgery or local therapies (e.g., ablation) that may affect evaluation of radiation-induced lung injury. * Missing follow-up data, making assessment of radiation-induced lung injury or long-term lung function changes impossible.
References
Publications (3)
- BACKGROUNDVinogradskiy Y, Castillo R, Castillo E, Tucker SL, Liao Z, Guerrero T, Martel MK. Use of 4-dimensional computed tomography-based ventilation imaging to correlate lung dose and function with clinical outcomes. Int J Radiat Oncol Biol Phys. 2013 Jun 1;86(2):366-71. doi: 10.1016/j.ijrobp.2013.01.004. Epub 2013 Mar 6. PMID 23474113
- BACKGROUNDHenshaw SK. Induced abortion: a world review, 1990. Fam Plann Perspect. 1990 Mar-Apr;22(2):76-89. PMID 2347411
- BACKGROUNDLombardo J, Castillo E, Castillo R, Miller R, Jones B, Miften M, Kavanagh B, Dicker A, Boyle C, Leiby B, Banks J, Simone NL, Movsas B, Grills I, Guerrero T, Rusthoven CG, Vinogradskiy Y. Prospective Trial of Functional Lung Avoidance Radiation Therapy for Lung Cancer: Quality of Life Report. Int J Radiat Oncol Biol Phys. 2024 Oct 1;120(2):593-602. doi: 10.1016/j.ijrobp.2024.03.046. Epub 2024 Apr 12. PMID 38614278