Deep Learning Model for Pure Solid Nodules Classification

September 14, 2022 updated by: Chang Chen

Deep Learning Model Supplementary PET-CT as a More Effectively Diagnostic Method for Pure Solid Nodules Classification: a Multicenter Observational Study

The purpose of this study is to compare the predictive performance of a CT-based deep learning model for pure-solid nodules classification and compared with the tumor maximum standardized uptake value on PET in a multicenter prospective cohort.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

260

Contacts and Locations

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

Study Locations

  • China
      • China, Gansu, China
        • Recruiting
        • Lanzhou
        • Contact:
      • China, Guizhou, China
        • Recruiting
        • Zunyi
        • Contact:
      • China, Jiangxi, China
        • Recruiting
        • Nanchang
        • Contact:
      • China, Zhejiang, China
        • Recruiting
        • Ningbo
        • Contact:
    • Shanghai
      • Yangpu, Shanghai, China
        • Recruiting
        • Shanghai Pulmonary Hospital

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

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with pulmonary radiological pure-solid nodules with size less than 3cm

Description

Inclusion Criteria:

  • Participants scheduled for surgery for radiological finding of pulmonary pure-solid lesions from the preoperative thin-section CT scans;
  • The maximum short-axis diameter of lymph nodes less than 3 cm on CT scan;
  • Age ranging from 18-75 years;
  • definied pathological examination report available;
  • Obtained written informed consent.

Exclusion Criteria:

  • Multiple lung lesions;
  • Poor quality of CT images;
  • Participants with incomplete clinical information;
  • Participants who have received neoadjuvant therapy before initial CT evaluation.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC
Time Frame: 2022.01-2023.12
Area under the curve of the receiver operating characteristic
2022.01-2023.12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy
Time Frame: 2022.01-2023.12
Ratio of the number of correctly classified samples to the total number of samples
2022.01-2023.12
sensitivity
Time Frame: 2022.01-2023.12
The probability of detecting a positive test in the population with the gold standard for disease (positive)
2022.01-2023.12
Specificity
Time Frame: 2022.01-2023.12
Odds of detecting a negative test in a population judged disease-free (negative) by the gold standard
2022.01-2023.12
PPV
Time Frame: 2022.01-2023.12
Positive predictive value
2022.01-2023.12
NPV
Time Frame: 2022.01-2023.12
Negative predictive value
2022.01-2023.12

Collaborators and Investigators

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

Sponsor

Chang Chen

Collaborators

Zunyi Medical College
Ningbo HwaMei Hospital, Zhejiang, China
The First Affiliated Hospital of Nanchang University, Jiangxi, China
The First Hospital of Lanzhou University, Gansu, China

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)

January 1, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

September 13, 2022

First Submitted That Met QC Criteria

September 14, 2022

First Posted (Actual)

September 16, 2022

Study Record Updates

Last Update Posted (Actual)

September 16, 2022

Last Update Submitted That Met QC Criteria

September 14, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • L21-022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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