NCT05542992

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 16, 2022

Status Verified

September 1, 2022

Enrollment Period

2 years

First QC Date

September 13, 2022

Last Update Submit

September 14, 2022

Conditions

Keywords

deep learning modelpure-solid nodulesPET-CT

Outcome Measures

Primary Outcomes (1)

  • AUC

    Area under the curve of the receiver operating characteristic

    2022.01-2023.12

Secondary Outcomes (5)

  • Accuracy

    2022.01-2023.12

  • sensitivity

    2022.01-2023.12

  • Specificity

    2022.01-2023.12

  • PPV

    2022.01-2023.12

  • NPV

    2022.01-2023.12

Interventions

CT-based deep learning model for pure-solid nodules classifications

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Shanghai Pulmonary Hospital

Yangpu, Shanghai Municipality, China

RECRUITING

Lanzhou

China, Gansu, China

RECRUITING

Zunyi

China, Guizhou, China

RECRUITING

Nanchang

China, Jiangxi, China

RECRUITING

Ningbo

China, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 13, 2022

First Posted

September 16, 2022

Study Start

January 1, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

September 16, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations