Using 4DCT Lung Ventilation Imaging to Optimize Radiotherapy for Lung Cancer

NCT ID: NCT07312682

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

202 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-09

Study Completion Date

2026-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lung Neoplasms Radiation Pneumonitis

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Second Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role lead

Responsible Party

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ZhenZhou Yang

Professor of Radiation Oncology, Cancer Center, Second Affiliated Hospital of Chongqing Medical University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cancer Center, Second Affiliated Hospital of Chongqing Medical University

Chongqing, , China

Site Status

Countries

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China

References

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Mattila S, Sovijarvi AR, Harjula A, Viljanen A, Takkunen O, Takkunen H, Mattila I, Mattila P, Merikallio E. Effects of mitral valve replacement on ventilation, volumes, diffusing capacity and regional perfusion of lungs in patients with mitral valve disease. Ann Chir Gynaecol. 1985;74(2):82-5.

Reference Type BACKGROUND
PMID: 3875308 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 2347411 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38614278 (View on PubMed)

Related Links

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https://www.medicalresearch.org.cn/clinicalResearch/researchInfo?id=8d854b86-67c5-4ecb-af5b-ba8120b32339

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

Other Identifiers

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IRB-2024-394

Identifier Type: -

Identifier Source: org_study_id