Deep Learning Signature for Predicting the Novel Grading System of Clinical Stage I Lung Adenocarcinoma

Recruiting

• Conditions: Lung Adenocarcinoma; Radiomics; Grading System

• Registration Number: NCT05736991
• 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 the grade 3 tumors based on the novel grading system in clinical stage stage I lung adenocarcinoma based on a multicenter prospective cohort.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-01
• Status Verified: 2023-02
• Study First Submitted: 2023-02-07
• Study First Submitted QC: 2023-02-12
• Last Update Submitted: 2023-02-12
• Study First Posted: 2023-02-21
• Last Update Posted: 2023-02-21
• Primary Completion: 2023-04-30
• Study Completion: 2023-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

(1) Participants scheduled for surgery for radiological finding of pulmonary lesions from the preoperative thin-section CT scans; (2) The maximum diameter of lesion less than 4 cm on CT scans; (3) The maximum short axis diameter of lymph nodes less than 1 cm on CT scan; (4) The SUVmax of hilar and mediastinal lymph nodes less than 2.5; (5) Pathological confirmation of primary lung adenocarcinoma; (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) Mucinous adenocarcinomas; (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	2022.11-2023.4	Area under the receiver operating characteristic curve

Secondary Outcome Measures

Name	Time	Method
Sensitivity	2022.11-2023.4	Sensitivity
Negative predictive value	2022.11-2023.4	Negative predictive value
Specificity	2022.11-2023.4	Specificity
Positive predictive value	2022.11-2023.4	Positive predictive value
Accuracy	2022.11-2023.4	Accuracy

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