Deep Learning for Preoperative Pulmonary Assessment in Thoracic CT

June 26, 2024 updated by: Jianxing He, The First Affiliated Hospital of Guangzhou Medical University

Application of Deep Learning in CT Imaging of Elective Thoracic Surgery Patients: Assessing Preoperative Abnormal Pulmonary Function

The trial was designed as a single-centre, non-interventional prospective observational study to utilize deep learning technology combined with computed tomography (CT) images to precisely predict the pulmonary function indicators of thoracic surgery preoperative patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Preoperative pulmonary function tests are crucial in assessing perioperative complications or mortality risks and providing decision support for thoracic surgery. However, traditional pulmonary function assessment methods have significant limitations, including long testing durations, difficulties in patient cooperation, high false-negative rates, and numerous contraindications. Thus, our study optimized the final model based on 1500 single inspiratory phase CTs by transferring model parameters trained on 500 dual-phase respiratory CTs, enhancing its predictive capabilities for pulmonary function. This adjustment suits real-world application demands, offering more convenient, comprehensive, and personalized preoperative pulmonary function assessment support. Our study optimized the final model based on 1500 single inspiratory phase CTs by transferring model parameters trained on 500 dual-phase respiratory CTs, enhancing its predictive capabilities for pulmonary function. This adjustment suits real-world application demands, offering more convenient, comprehensive, and personalized preoperative pulmonary function assessment support.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Elective Thoracic Surgery Patients

Description

Inclusion Criteria:

  • (1) Signing of the informed consent form;
  • (2) Male or female, aged 18-75 years;
  • (3) Undergoing elective thoracic surgery;
  • (4) Good preoperative pulmonary function cooperation and complete reporting;
  • (5) Preoperative chest single/dual phase CT scans without significant artefacts and with complete imaging;
  • (6) The interval between preoperative pulmonary function and single/dual phase CT scans does not exceed one month.

Exclusion Criteria:

  • (1) Poor preoperative pulmonary function cooperation or missing reports;
  • (2) Preoperative chest single/dual phase CT scans exhibit significant artefacts or image omission;
  • (3) The interval between preoperative pulmonary function and single/dual phase CT scans exceeds one month;
  • (4) Complication with severe respiratory disorders (such as lung transplantation, pneumothorax, giant bullae, etc.);
  • (5) Coexisting with other severe functional impairments;
  • (6) Patients with obstructive lesions such as airway or esophageal stenosis;
  • (7) Height beyond the predicted equation range (Female < 1.45m; Male < 1.55m);
  • (8) Medication use before pulmonary function testing that does not meet the cessation guidelines;
  • (9) Pulmonary function report quality graded D-F.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Single inspiratory phase cohort
Patients in this cohort undergo single inspiratory phase CT and pulmonary function tests preoperatively.
Other: Single inspiratory phase computed tomography.
Utilizing deep learning technology in conjunction with single inspiratory phase computed tomography images to accurately predict the pulmonary function indicators of preoperative thoracic surgery patients.
Respiratory dual-phase cohort
Patients in this cohort undergo respiratory dual-phase CT and pulmonary function tests preoperatively.
Other: Respiratory dual-phase computed tomography.
Utilizing deep learning technology in conjunction with respiratory dual-phase computed tomography images to accurately predict the pulmonary function indicators of preoperative thoracic surgery patients.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Absolute Error（MAE）
Time Frame: 2 years
Used to assess the discrepancy between pulmonary function predictions made by the deep learning algorithm and actual results obtained from pulmonary function tests (measured with a spirometer).
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Concordance Correlation Coefficient（CCC）
Time Frame: 2 years
Used to assess the discrepancy between pulmonary function predictions made by the deep learning algorithm and actual results obtained from pulmonary function tests (measured with a spirometer).
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Affiliated Hospital of Guangzhou Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GE Healthcare

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jianxing He, MD, Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 27, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ES-2024-091-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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