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

Lung Adenocarcinoma Clinical Trial

Official title:

Deep Learning Signature Based on PET-CT Images for Predicting the Novel Grading System of Clinical Stage I Lung Adenocarcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05736991
• Other study ID #: DLGS
• Status: Recruiting
• Start date: November 1, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: February 2023
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Lung
• Lung Adenocarcinoma
• Radiomics

Intervention

Diagnostic Test:
• PET/CT-based Radiomics Signature
Radiomics Signature Based on PET-CT for Predicting the Novel Grading System of Clinical Stage I Lung Adenocarcinoma

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Ningbo HwaMei Hospital	Ningbo	Zhejiang
China	Shanghai Pulmonary Hospital	Yangpu	Shanghai
China	Affiliated Hospital of Zunyi Medical University	Zunyi	Guizhou

Sponsors (4)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China	Ningbo HwaMei Hospital, Zhejiang, China, The First Affiliated Hospital of Nanchang University, Jiangxi, China, Zunyi Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the receiver operating characteristic curve	Area under the receiver operating characteristic curve	2022.11-2023.4
Secondary	Sensitivity	Sensitivity	2022.11-2023.4
Secondary	Specificity	Specificity	2022.11-2023.4
Secondary	Positive predictive value	Positive predictive value	2022.11-2023.4
Secondary	Negative predictive value	Negative predictive value	2022.11-2023.4
Secondary	Accuracy	Accuracy	2022.11-2023.4