4DCT Ventilation Imaging-Guided Functional Lung Avoidance Radiotherapy: A Prospective Single-Arm Study

NCT ID: NCT07339644

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-24
• Study Completion Date: 2027-12-24

Brief Summary

This prospective, single-center, single-arm study will evaluate the feasibility and safety of 4DCT ventilation functional imaging-guided functional lung avoidance radiotherapy (FLAR) in patients with lung malignancies receiving IMRT radiotherapy.

All participants will undergo 4DCT simulation as part of routine radiotherapy preparation. A ventilation map will be generated from 4DCT data, and the top 80% ventilation region will be defined as the high-function lung. This structure will be imported into the treatment planning system to create an FLAR plan that prioritizes sparing of high-function lung while maintaining target coverage (PTV D95%) and meeting standard dose constraints for organs at risk. A conventional anatomic plan (without functional guidance) will also be created for paired, within-patient dosimetric comparison.

The primary outcome is improvement in dosimetric sparing of the high-function lung (V10, V20, V30, and mean lung dose). Secondary outcomes include the incidence of grade ≥2 radiation pneumonitis (CTCAE v5.0), changes in pulmonary function (e.g., FEV1 and DLCO), and lung-related quality-of-life scores. Assessments will be performed mid-treatment (after 15 fractions), at the end of radiotherapy (after 30 fractions), and at 1, 3, 6, and 12 months after radiotherapy. The study plans to enroll 100 participants and follow each participant for 12 months.

Conditions

Lung Cancer (Including Metastatic Cancer); Radiation Pneumonitis; Radiation-induced Lung Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

4DCT-FLI-Guided Functional Lung Avoidance Radiotherapy (FLAR)

Participants receive IMRT planned with 4DCT ventilation functional imaging guidance. A ventilation map is generated from 4DCT, high-function lung (top 80% ventilation) is contoured, and the treatment plan is optimized to spare high-function lung while maintaining target coverage and meeting standard OAR constraints. A conventional anatomic plan is also generated for within-patient dosimetric comparison.

Group Type: EXPERIMENTAL

4DCT Ventilation Imaging-Guided Functional Lung Avoidance Radiotherapy (FLAR)

Intervention Type: PROCEDURE

All participants undergo 4DCT simulation. A ventilation map is generated from 4DCT data, and the high-function lung is defined as the top 80% ventilation region. This structure is imported into the treatment planning system, and an IMRT plan is optimized to preferentially spare high-function lung while maintaining target (PTV) coverage and meeting standard organ-at-risk constraints. A conventional anatomic plan (without functional guidance) is also created for within-patient paired dosimetric comparison.

Interventions

4DCT Ventilation Imaging-Guided Functional Lung Avoidance Radiotherapy (FLAR)

All participants undergo 4DCT simulation. A ventilation map is generated from 4DCT data, and the high-function lung is defined as the top 80% ventilation region. This structure is imported into the treatment planning system, and an IMRT plan is optimized to preferentially spare high-function lung while maintaining target (PTV) coverage and meeting standard organ-at-risk constraints. A conventional anatomic plan (without functional guidance) is also created for within-patient paired dosimetric comparison.

Intervention Type: PROCEDURE

Other Intervention Names

Functional Lung Avoidance Radiotherapy; 4DCT-FLAR; 4DCT Ventilation Functional Imaging (4DCT-FLI)-Guided Radiotherapy

Eligibility Criteria

Inclusion Criteria

• Age 18 to 85 years (inclusive); any sex.
• Diagnosed lung malignancy requiring thoracic radiotherapy (e.g., non-small cell lung cancer, small cell lung cancer, or pulmonary metastases).
• Planned to receive thoracic radiotherapy using either conventionally fractionated IMRT/VMAT or stereotactic body radiotherapy (SBRT), and able to complete pre-treatment 4DCT simulation suitable for generating a ventilation map.
• Adequate baseline organ function and clinically judged able to tolerate radiotherapy; ECOG performance status 0-1.
• No absolute contraindication to pulmonary function testing; patients with moderate COPD or impaired lung function may be included if the treating team judges radiotherapy to be tolerable.
• Able to comply with treatment and follow-up assessments.
• Written informed consent provided.

Exclusion Criteria

• Pregnant or breastfeeding women. Women of childbearing potential must have pregnancy excluded prior to radiotherapy per institutional practice.
• Age <18 or >85 years.
• Uncontrolled severe cardiopulmonary disease or other severe comorbidities that make radiotherapy excessively high risk (e.g., decompensated heart failure, unstable cardiopulmonary status, active severe pulmonary infection).
• Prior high-dose thoracic radiotherapy to the same region such that safe re-irradiation is not feasible.
• Concurrent other active/advanced malignancy requiring priority treatment that would confound study outcomes.
• Recent participation in another interventional clinical trial or concurrent investigational therapy judged likely to interfere with this study's endpoints.
• Severe psychiatric, cognitive, or other conditions that prevent cooperation with radiotherapy and/or scheduled follow-up.
• Inadequate 4DCT image quality or inability to generate/validate the 4DCT ventilation map required for functional-lung-guided planning.
• Any other condition deemed unsuitable by the investigators in the interest of participant safety.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role: lead

Responsible Party

ZhenZhou Yang

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

zhengjun Guo, MD.

Role: PRINCIPAL_INVESTIGATOR

The Second Clinical College of Chongqing Medical University: The Second Affiliated Hospital of Chongqing Medical University

Locations

Cancer Center, Second Affiliated Hospital of Chongqing Medical University

Chongqing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhi chen, MD.

Role: CONTACT

2023440076@stu.cqmu.edu.cn

+86 18982928222

Facility Contacts

Xiongying Fang, MD.

Role: primary

1270161476@qq.com

+86 23 62888436

References

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: RESULT

PMID: 3875308 (View on PubMed)

Other Identifiers

IRB-2025-243

Identifier Type: -

Identifier Source: org_study_id