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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4DCT-FLI-Guided Functional Lung Avoidance Radiotherapy (FLAR) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4DCT Ventilation Imaging-Guided Functional Lung Avoidance Radiotherapy (FLAR) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Time Frame: Assessed at 3 months, 6 months, and 12 months after completion of radiotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Dose to High-Function Lung (Gy) | DVH-derived mean dose to ventilation-defined high-function lung on paired plans (functional-lung-avoidance vs conventional plans). Lower dose indicates better sparing. | At baseline treatment planning (prior to radiotherapy delivery).] |
| MLD for Whole Lung (Gy) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhi chen, MD. | Contact | +86 18982928222 | 2023440076@stu.cqmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| zhengjun Guo, MD. | The Second Clinical College of Chongqing Medical University: The Second Affiliated Hospital of Chongqing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Center, Second Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | 400000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23474113 | Result | 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. |
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Single-arm, single-center prospective study. All participants receive 4DCT ventilation imaging-guided functional lung avoidance radiotherapy (FLAR). For within-patient paired dosimetric comparison, a conventional anatomic plan (non-functional plan) is also generated for each participant.
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Percentage volume (%) of ventilation-defined high-function lung receiving ≥5 Gy, reported separately for functional-lung-avoidance and conventional radiotherapy plans. |
| At baseline treatment planning (prior to radiotherapy delivery). |
| V5 of High-Function Lung (%) | Percentage volume (%) of ventilation-defined high-function lung receiving ≥5 Gy, reported separately for functional-lung-avoidance and conventional radiotherapy plans. | At baseline treatment planning (prior to radiotherapy delivery). |
| V20 of High-Function Lung(%) | DVH-derived V20 of ventilation-defined high-function lung, defined as the percentage of lung volume receiving ≥20 Gy, compared between functional-lung-avoidance and conventional radiotherapy plans. | At baseline treatment planning (prior to radiotherapy delivery). |
| Mean Dose to Heart (Gy) | DVH-derived mean dose (Dmean) to the heart, compared between functional-lung-avoidance and conventional radiotherapy plans. | At treatment planning (baseline, pre-radiotherapy delivery). |
| Maximum Dose to Esophagus (Gy) | DVH-derived maximum dose (Dmax) to the esophagus, compared between functional-lung-avoidance and conventional radiotherapy plans. | At treatment planning (baseline, pre-radiotherapy delivery).] |
| Maximum Dose to Spinal Cord (Gy) | DVH-derived maximum dose (Dmax) to the spinal cord, compared between functional-lung-avoidance and conventional radiotherapy plans. | At treatment planning (baseline, pre-radiotherapy delivery). |
| Target Coverage (PTV D95) | Percentage of planning target volume (PTV) receiving at least 95% of prescribed dose, compared between functional-lung-avoidance and conventional plans. | At treatment planning (baseline, pre-radiotherapy delivery). |
| Conformity Index of Radiotherapy Plans | Conformity Index (CI) of paired treatment plans, comparing functional-lung-avoidance and conventional anatomic radiotherapy plans. The Conformity Index is defined as the ratio of the prescription isodose volume to the target volume (CI = VRI / VT). The score ranges from 1.0 to >2.0, where a value closer to 1.0 indicates better conformity and thus higher plan quality. | At treatment planning (baseline, pre-radiotherapy delivery). |
| Homogeneity Index of Radiotherapy Plans | Homogeneity Index (HI) of paired treatment plans, comparing functional-lung-avoidance and conventional anatomic radiotherapy plans. The Homogeneity Index is defined as (D2% - D98%) / D50%. The score typically ranges from 0 to 1.0, where lower values indicate more homogeneous dose distribution and better plan quality. | At treatment planning (baseline, pre-radiotherapy delivery). |
| Gradient Measure (GM) of Radiotherapy Plans | Gradient Measure (cm) of paired radiotherapy plans, comparing 4DCT-FLI-guided functional lung avoidance plans and conventional anatomic plans. GM is defined as the difference between the equivalent sphere radii of the 50% and 100% prescription isodose volumes (GM = R50% - R100%); lower values indicate steeper dose fall-off and better plan quality. | At treatment planning (baseline, pre-radiotherapy delivery). |
| Forced Expiratory Volume in 1 Second (FEV1) | FEV1 measured by standardized spirometry (L and % predicted). Outcome is change from baseline. | Baseline and 1, 3, 6, and 12 months after radiotherapy. |
| Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) | DLCO measured using a standardized single-breath method (mL/min/mmHg and % predicted). Outcome is change from baseline. | Baseline and 1, 3, 6, and 12 months after radiotherapy. |
| Forced Vital Capacity (FVC) | FVC measured by standardized spirometry (L and % predicted). Outcome is change from baseline. | Baseline and 1, 3, 6, and 12 months after radiotherapy. |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D017564 | Radiation Pneumonitis |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D017563 | Lung Diseases, Interstitial |
| D055370 | Lung Injury |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
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