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AzTrials

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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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

Other trials in Hong Kong

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.

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 groups in NCT07256457
Study groupRoleWhat they receive
Segmentectomy GroupExperimentalNot described
Receives: Procedure: Segmentectomy
Lobectomy GroupExperimentalNot described
Receives: Procedure: Lobectomy
Bronchoscopic Ablation GroupExperimentalNot described
Receives: Procedure: Bronchoscopic Ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. 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)

  2. 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)

  3. 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.

  1. First posted1 Dec 2025
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion30 Jun 2029 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

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)
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

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.

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