Deep Learning Signature for Predicting Occult Nodal Metastasis of Clinical N0 Lung Cancer

Recruiting

• Conditions: Non-small Cell Lung Cancer

• Registration Number: NCT05425134
• Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

Brief Summary

The purpose of this study is to evaluate the performance of a PET/CT-based deep learning signature for predicting occult nodal metastasis of clinical stage N0 non-small cell lung cancer in a multicenter prospective cohort.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-06-15
• Study First Submitted QC: 2022-06-15
• Study First Posted: 2022-06-21
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-09
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

(1) Participants scheduled for surgery for radiological finding of pulmonary lesions from the preoperative thin-section CT scans; (2) The maximum short-axis diameter of N1 and N2 lymph nodes less than 1 cm on CT scan; (3) The SUVmax of N1 and N2 lymph nodes less than 2.5; (4) Pathological confirmation of primary NSCLC; (5) Age ranging from 20-75 years; (6) Obtained written informed consent.

Exclusion Criteria

(1) Multiple lung lesions; (2) Poor quality of PET-CT images; (3) Participants with incomplete clinical information; (4) Participants not receiving systematic lymph node dissection; (5) Participants who have received neoadjuvant therapy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Area under the receiver operating characteristic curve	2022.1-2023.12	Area under the receiver operating characteristic curve

Secondary Outcome Measures

Name	Time	Method
Accuracy	2022.1-2023.12	Accuracy
Positive predictive value	2022.1-2023.12	Positive predictive value
Negative predictive value	2022.1-2023.12	Negative predictive value
Sensitivity Sensitivity	2022.1-2023.12	Sensitivity
Specificity	2022.1-2023.12	Specificity

Trial Locations

Locations (4)

Affiliated Hospital of Zunyi Medical University; 🇨🇳 Zunyi, Guizhou, China

Shanghai Pulmonary Hospital; 🇨🇳 Yangpu, Shanghai, China

The First Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China

Ningbo HwaMei Hospital; 🇨🇳 Ningbo, Zhejiang, China