Using 4DCT Lung Ventilation Imaging to Optimize Radiotherapy for Lung Cancer (FLAR-4DCT)

Chongqing Medical University

Status: Active, not recruiting

Conditions: Lung Neoplasms; Radiation Pneumonitis

Study type: Observational

Funder types: Other

Identifiers

NCT07312682

IRB-2024-394

Details and patient eligibility

About

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.

Full description

This study retrospectively evaluates a functional lung-guided radiotherapy planning workflow based on four-dimensional CT (4DCT) ventilation imaging in patients with primary lung cancer who previously underwent thoracic radiotherapy.

High-quality 4DCT datasets acquired during routine simulation are processed to generate voxel-based lung ventilation maps using deformable image registration and Jacobian-based computational methods. These ventilation maps are spatially registered to planning CT images and incorporated into the treatment planning system to delineate high-function lung subregions.

For each eligible patient, paired radiotherapy plans are retrospectively generated and analyzed: a conventional anatomic radiotherapy plan and a functional lung avoidance radiotherapy (FLAR) plan that incorporates ventilation-defined avoidance structures. Both plans are optimized to achieve comparable target coverage while differing in lung avoidance strategy.

Dosimetric and clinical data are obtained from existing treatment planning records and routine clinical follow-up to support comparative analyses of functional lung sparing and associated pulmonary outcomes. All analyses are conducted retrospectively using data derived from standard clinical care. No prospective enrollment, additional imaging, or study-specific interventions are performed.

Enrollment: 202 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

202 participants in 1 patient group

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.