Application of 4DCT-Based Pulmonary Ventilation Imaging in Lung Cancer Radiotherapy

NCT07312682 | Active Not Recruiting DMC

• 1 other identifier: IRB-2024-394
• Study Type: observational
• Target: 202
• Locations: 1 country
• Sites: 1

Brief Summary

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

Radiation Pneumonitis; Lung Neoplasms

Keywords

4DCT; Lung Ventilation Imaging; Functional Lung Imaging; Functional-Lung-Avoidance Radiotherapy (FLAR); IMRT; Organs at Risk (OARs); Radiation-Induced Lung Injury; Radiation Pneumonitis

Outcome Measures

Primary Outcomes (1)

• Incidence of Radiation-Induced Lung Injury (Grade ≥2)

  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.

  Assessed at 3 months, 6 months, and 12 months after completion of radiotherapy.

Secondary Outcomes (10)

• Mean Dose to High-Function Lung (Gy)

  At baseline treatment planning (prior to radiotherapy delivery).

• MLD for Whole Lung (Gy)

  At treatment planning (baseline, pre-radiotherapy delivery).

• V5 of High-Function Lung (%)

  At baseline treatment planning (prior to radiotherapy delivery).

• V20 of High-Function Lung

  At baseline treatment planning (prior to radiotherapy delivery).

• Mean Dose to Heart (Gy)

  At treatment planning (baseline, pre-radiotherapy delivery).

Study Arms (1)

4DCT-IMRT Lung Cancer Cohort

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Single-center retrospective cohort of consecutive adults (≥18 years) with primary lung cancer treated with thoracic radiotherapy planned with IMRT, with adequate 4DCT scans for ventilation mapping (2022-01-01 to 2025-09-09).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

Cancer Center, Second Affiliated Hospital of Chongqing Medical University

Chongqing, 400000, China

Location

Related Publications (3)

• Vinogradskiy 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 BACKGROUND

• Henshaw SK. Induced abortion: a world review, 1990. Fam Plann Perspect. 1990 Mar-Apr;22(2):76-89.

  PMID: 2347411 BACKGROUND

• Lombardo 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 BACKGROUND

Related Links

• National Clinical Research Registration and Filing Information System (China) record for this study(ID：MR-50-25-001899).

MeSH Terms

Conditions

Lung Neoplasms; Radiation Pneumonitis

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Interstitial; Lung Injury; Radiation Injuries; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiation Oncology, Cancer Center, Second Affiliated Hospital of Chongqing Medical University

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: December 31, 2025
• Study Start: December 9, 2024
• Primary Completion: September 9, 2025
• Study Completion (Estimated): November 30, 2026
• Last Updated: February 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: De-identified IPD and supporting documents will be available from publication of the primary results until 2035-08-31. Requests will be reviewed within 30 days of receipt and, if approved, data will be shared within 60 days after execution of a Data Use Agreement.
• Access Criteria: Qualified researchers with a methodologically sound proposal and evidence of IRB/ethics approval may request access. A Data Use Agreement with the sponsor institution is required. Only de-identified data will be shared; no re-identification, redistribution, or commercial use is permitted. Data will be transferred via secure, access-controlled methods. Please contact Zhi Chen (2023440076@stu.cqmu.edu.cn).

Locations

CN (1)