Lung Cancer (NSCLC)NCT07256457
Postoperative Pulmonary Function Assessment Based on Deep Learning Study
A study testing Segmentectomy, Lobectomy and Bronchoscopic Ablation in people with Lung Cancer (NSCLC), run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Improvements in low-dose CT screening have led to an increase in early-stage NSCLC diagnoses, with surgical resection-usually lobectomy or segmentectomy-remaining the primary curative option. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer (NSCLC)
- What is being tested?
- Segmentectomy, Lobectomy and Bronchoscopic Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Nov 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Histologically or cytologically confirmed stage IA NSCLC (T1N0M0, tumor ≤3 cm)
- Scheduled for surgical treatment (segmentectomy or lobectomy or robotic/navigation-guided bronchoscopic ablation)
- Ability to complete postoperative visits for up to 2 years
- Provided informed consent
Who cannot join
- Presence of lymph node involvement (N1 or higher) or distant metastases (M1)
- Concomitant primary malignancies that could confound outcome analysis
- Insufficient or missing key data points (e.g., tumor size, treatment type, survival status)
- Duplicate or overlapping records from different data sources
- Contraindications to anesthesia or sedation for bronchoscopy or surgery
- Inability or unwillingness to perform the PF tests
- Pregnant or breastfeeding women (for prospective phase)
- Inability or unwillingness to comply with study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
Prince of Wales Hospital
Shatin
Calvin Sze Hang Ng, +852 3505 2618, calvinng@surgery.cuhk.edu.hk
About this study
Official title: Multimodal Machine Learning Integration of Pulmonary Function Parameters and 3D-CT Imaging for Postoperative Outcome Prediction in Early-Stage NSCLC
Improvements in low-dose CT screening have led to an increase in early-stage NSCLC diagnoses, with surgical resection-usually lobectomy or segmentectomy-remaining the primary curative option. In Hong Kong, however, patients frequently present with comorbidities such as chronic respiratory disease or cardiovascular issues, making the preservation of healthy lung tissue crucial for their long-term quality of life. Traditional surgical resection, such as lobectomy or segmentectomy, has certain limitations in terms of functional preservation. In contrast, robotic/navigational bronchoscopic ablation has emerged in recent years as a novel minimally invasive endoscopic treatment strategy. This approach has been implemented in select centers and demonstrates potential advantages, including faster postoperative recovery, reduced trauma, and improved preservation of pulmonary function. By leveraging advanced navigation systems, bronchoscopic ablation enables precise localization and ablation of pulmonary nodules, avoiding the extensive resection of healthy lung tissue required in traditional surgery. These benefits hold promise for enhancing patients' long-term quality of life and survival rates.
Moreover, conventional pulmonary function tests like FEV₁ and diffusing capacity of the lung for carbon monoxide provide only a global assessment of respiratory capacity, which may not fully capture the regional changes in pulmonary function that occur following segmentectomy or lobectomy. Likewise, basic CT volumetry overlooks finer anatomical details such as segmental airway distribution, microvascular networks, and local alveolar compliance. Furthermore, there is currently a paucity of direct comparative studies between robotic/navigational bronchoscopic ablation and traditional surgical resection regarding postoperative pulmonary function and long-term outcomes. Supported by Research Grants Council, our work since 2019 has validated the feasibility and safety of this technique, leading to widespread recognition and numerous publications. However, most existing research is retrospective or derived from single-center data, with a primary focus on short-term safety and technical feasibility.
Read more
To address these limitations, an integrative approach leveraging 3D-CT imaging and ML is proposed. Machine learning is a technology that uses algorithms to automatically learn from data and make predictions or decisions. Deep learning, a subfield of ML, utilizes multi-layer neural networks to effectively extract features and recognize patterns in complex, high-dimensional data. ML, and particularly DL, has demonstrated remarkable potential in various medical imaging applications, including lesion detection, tissue segmentation, and outcome prediction. By automatically learning complex patterns in high-dimensional data, ML and DL models can interpret subtle radiologic characteristics that may be missed by conventional analyses. In the context of 3D-CT imaging for NSCLC, DL architectures-such as convolutional neural networks-can extract detailed features from volumetric scans, enabling robust quantification of tumor size, shape, and location as well as refined assessment of lung parenchyma. When integrated with pulmonary function parameters and clinical data, these algorithms provide a powerful means to generate predictive models, identify at-risk patients earlier, and guide individualized treatment planning. Moreover, ML-driven approaches can adapt to evolving datasets over time, continuously refining and improving their performance. This scalability and adaptability are especially valuable in prospective studies, where large, multimodal datasets are collected to evaluate the long-term impact of different treatment strategies. Consequently, incorporating ML and DL in this research not only enhances the precision of outcome prediction but also contributes to a standardized framework for dynamic, personalized assessment of pulmonary function, guiding more informed clinical decision-making.
The primary aim of this study is to determine whether segmentectomy truly offers better functional preservation than lobectomy, whether robotic/navigation-guided bronchoscopic ablation indeed achieves superior pulmonary function preservation compared to traditional surgical resection, and under which specific patient conditions each approach may yield the greatest benefit. By undertaking a prospective, well-designed investigation, the research will fill a critical gap in evidence regarding long-term functional outcomes, providing clearer criteria for selecting the most appropriate resection type. Moreover, the introduction of a standardized, integrative assessment tool has the potential to optimize surgical decision-making and postoperative care, ultimately improving survival and quality of life for early-stage NSCLC patients in Hong Kong and potentially informing best practices in other healthcare contexts.
- Conditions
- Lung Cancer (NSCLC)
- Being tested
- Segmentectomy, Lobectomy, Bronchoscopic Ablation
- Keywords
- Non-small cell lung cancer, Pulmonary function score, Machine learning, 3D-CT imaging, Robotic bronchoscopy, Navigational bronchoscopy, Segmentectomy, Lobectomy, Postoperative outcomes
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SegmentectomyProcedure or surgery
with 64 participants
LobectomyProcedure or surgery
with 64 participants
Bronchoscopic AblationProcedure or surgery
with 64 participants
| Study group | Role | What they receive |
|---|---|---|
| Segmentectomy Group | Experimental | Not described Receives: Procedure: Segmentectomy |
| Lobectomy Group | Experimental | Not described Receives: Procedure: Lobectomy |
| Bronchoscopic Ablation Group | Experimental | Not described Receives: Procedure: Bronchoscopic Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop and validate a composite PF score
Develop and validate a composite PF score by applying ML algorithms to integrate pulmonary function test results (FEV₁, FVC, DLCO), 3D-CT volumetric data (segmental volumes, vascular density) (Figure 1), and basic demographic variables (age, BMI). The primary objective is to predict changes in postoperative pulmonary function at 1, 3, 6, 12, 18, and 24 months.
Measured: 1, 3, 6, 12, 18, and 24 months (post-operation)
Secondary outcomes (3)
To compare the time trajectory of the PF score
Compare the time trajectory of the PF score among patients undergoing different treatment approaches-segmentectomy, lobectomy, and robotic/navigation-guided bronchoscopic ablation-to determine which method offers a superior advantage in long-term postoperative pulmonary function preservation.
Measured: at 1, 3, 6, 12, 18, and 24 months (post-operation)
To Correlate the PF score with overall survival, cancer-specific survival, and postoperative complications
Correlate the PF score with overall survival, cancer-specific survival, and postoperative complications, assessing its utility as a clinical endpoint.
Measured: at 1, 3, 6, 12, 18, and 24 months (post-operation)
To identify key predictive factors-including tumor location, histology, and baseline comorbidities
Identify key predictive factors-including tumor location, histology, and baseline comorbidities-that may influence postoperative functional decline or survival. Additionally, conduct a preliminary investigation into the application of robotic/navigation-guided bronchoscopic ablation in high-risk patients.
Measured: at 1, 3, 6, 12, 18, and 24 months (post-operation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start1 Nov 2026 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Calvin Sze Hang Ng, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07256457
- Sponsor's protocol ID
- Protocol version 1.0
- Status last verified
- Oct 2026
- First submitted
- 20 Nov 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Machine Learning Integration of Pulmonary Function Parameters and 3D-CT Imaging for Postoperative Outcome Prediction in Early-Stage NSCLC
- ClinicalTrials.gov ID
- NCT07256457
- Acronym / sponsor ID
- Protocol version 1.0
- Conditions
- Lung Cancer (NSCLC)
- Keywords
- Non-small cell lung cancer, Pulmonary function score, Machine learning, 3D-CT imaging, Robotic bronchoscopy, Navigational bronchoscopy, Segmentectomy, Lobectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 1 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Improvements in low-dose CT screening have led to an increase in early-stage NSCLC diagnoses, with surgical resection-usually lobectomy or segmentectomy-remaining the primary curative option. In Hong Kong, however, patients frequently present with comorbidities such as chronic respiratory disease or cardiovascular issues, making the preservation of healthy lung tissue crucial for their long-term quality of life. Traditional surgical resection, such as lobectomy or segmentectomy, has certain limitations in terms of functional preservation. In contrast, robotic/navigational bronchoscopic ablation has emerged in recent years as a novel minimally invasive endoscopic treatment strategy. This approach has been implemented in select centers and demonstrates potential advantages, including faster postoperative recovery, reduced trauma, and improved preservation of pulmonary function. By leveraging advanced navigation systems, bronchoscopic ablation enables precise localization and ablation of pulmonary nodules, avoiding the extensive resection of healthy lung tissue required in traditional surgery. These benefits hold promise for enhancing patients' long-term quality of life and survival rates.
Moreover, conventional pulmonary function tests like FEV₁ and diffusing capacity of the lung for carbon monoxide provide only a global assessment of respiratory capacity, which may not fully capture the regional changes in pulmonary function that occur following segmentectomy or lobectomy. Likewise, basic CT volumetry overlooks finer anatomical details such as segmental airway distribution, microvascular networks, and local alveolar compliance. Furthermore, there is currently a paucity of direct comparative studies between robotic/navigational bronchoscopic ablation and traditional surgical resection regarding postoperative pulmonary function and long-term outcomes. Supported by Research Grants Council, our work since 2019 has validated the feasibility and safety of this technique, leading to widespread recognition and numerous publications. However, most existing research is retrospective or derived from single-center data, with a primary focus on short-term safety and technical feasibility.
To address these limitations, an integrative approach leveraging 3D-CT imaging and ML is proposed. Machine learning is a technology that uses algorithms to automatically learn from data and make predictions or decisions. Deep learning, a subfield of ML, utilizes multi-layer neural networks to effectively extract features and recognize patterns in complex, high-dimensional data. ML, and particularly DL, has demonstrated remarkable potential in various medical imaging applications, including lesion detection, tissue segmentation, and outcome prediction. By automatically learning complex patterns in high-dimensional data, ML and DL models can interpret subtle radiologic characteristics that may be missed by conventional analyses. In the context of 3D-CT imaging for NSCLC, DL architectures-such as convolutional neural networks-can extract detailed features from volumetric scans, enabling robust quantification of tumor size, shape, and location as well as refined assessment of lung parenchyma. When integrated with pulmonary function parameters and clinical data, these algorithms provide a powerful means to generate predictive models, identify at-risk patients earlier, and guide individualized treatment planning. Moreover, ML-driven approaches can adapt to evolving datasets over time, continuously refining and improving their performance. This scalability and adaptability are especially valuable in prospective studies, where large, multimodal datasets are collected to evaluate the long-term impact of different treatment strategies. Consequently, incorporating ML and DL in this research not only enhances the precision of outcome prediction but also contributes to a standardized framework for dynamic, personalized assessment of pulmonary function, guiding more informed clinical decision-making.
The primary aim of this study is to determine whether segmentectomy truly offers better functional preservation than lobectomy, whether robotic/navigation-guided bronchoscopic ablation indeed achieves superior pulmonary function preservation compared to traditional surgical resection, and under which specific patient conditions each approach may yield the greatest benefit. By undertaking a prospective, well-designed investigation, the research will fill a critical gap in evidence regarding long-term functional outcomes, providing clearer criteria for selecting the most appropriate resection type. Moreover, the introduction of a standardized, integrative assessment tool has the potential to optimize surgical decision-making and postoperative care, ultimately improving survival and quality of life for early-stage NSCLC patients in Hong Kong and potentially informing best practices in other healthcare contexts.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Segmentectomy Group | Experimental | Procedure: Segmentectomy |
| Lobectomy Group | Experimental | Procedure: Lobectomy |
| Bronchoscopic Ablation Group | Experimental | Procedure: Bronchoscopic Ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- Histologically or cytologically confirmed stage IA NSCLC (T1N0M0, tumor ≤3 cm)
- Scheduled for surgical treatment (segmentectomy or lobectomy or robotic/navigation-guided bronchoscopic ablation)
- Ability to complete postoperative visits for up to 2 years
- Provided informed consent
Key exclusion criteria (8 listed)
- Presence of lymph node involvement (N1 or higher) or distant metastases (M1)
- Concomitant primary malignancies that could confound outcome analysis
- Insufficient or missing key data points (e.g., tumor size, treatment type, survival status)
- Duplicate or overlapping records from different data sources
- Contraindications to anesthesia or sedation for bronchoscopy or surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Segmentectomywith 64 participants | Procedure or surgery | Segmentectomy Group |
| Lobectomywith 64 participants | Procedure or surgery | Lobectomy Group |
| Bronchoscopic Ablationwith 64 participants | Procedure or surgery | Bronchoscopic Ablation Group |
Primary outcome
Develop and validate a composite PF score
Time frame: 1, 3, 6, 12, 18, and 24 months (post-operation)
Develop and validate a composite PF score by applying ML algorithms to integrate pulmonary function test results (FEV₁, FVC, DLCO), 3D-CT volumetric data (segmental volumes, vascular density) (Figure 1), and basic demographic variables (age, BMI). The primary objective is to predict changes in postoperative pulmonary function at 1, 3, 6, 12, 18, and 24 months.
3 secondary outcomes
To compare the time trajectory of the PF score
Time frame: at 1, 3, 6, 12, 18, and 24 months (post-operation)
To Correlate the PF score with overall survival, cancer-specific survival, and postoperative complications
Time frame: at 1, 3, 6, 12, 18, and 24 months (post-operation)
To identify key predictive factors-including tumor location, histology, and baseline comorbidities
Time frame: at 1, 3, 6, 12, 18, and 24 months (post-operation)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Segmentectomy, Lobectomy and Bronchoscopic Ablation in people with Lung Cancer (NSCLC), run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Calvin Sze Hang Ng (+852 3505 2618, calvinng@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Develop and validate a composite PF score (time frame: 1, 3, 6, 12, 18, and 24 months (post-operation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.