The Accuracy of Targeted Lymph Node Dissection of Non-small Cell Lung Cancer Patients According to Predictive Models

Clinical Study on Predicting Mediastinal Lymph Node Metastasis in Patients with Lung Cancer by the Predictive Model Based on Clinical Characteristics and Radiomics

Investigators combined the clinical and radiomics characteristics of resectable non-small cell lung cancer patients to construct an accurate model for preoperative prediction of mediastinal lymph node status. For the patients in the experimental group, lymph nodes will be dissected based on the predicted lymph node status by the model, while in the control group, the lymph nodes will be dissected according to the NCCN guidelines (2023). Investigators expect that performing lymph node dissection according to the predictive model can lead to better prognosis for patients.

Study Overview

• Status: Not yet recruiting
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Procedure: Lymph node dissection based on the model; Procedure: Lymph node dissection based on the guidelines

Detailed Description

Investigators combined the clinical and radiomics characteristics of resectable non-small cell lung cancer patients to construct an accurate model for preoperative prediction of mediastinal lymph node status. Investigators will randomly divide all enrolled patients into an experimental group and a control group. For the patients in the experimental group, lymph nodes will be dissected based on the predicted lymph node status by the model, while in the control group, the lymph nodes will be dissected according to the NCCN guidelines (2023). Investigators will calculate the consistency between preoperative prediction results and postoperative pathological results to verify the accuracy of the model. And investigators will evaluate the impact of this new lymph node dissection method on prognosis by comparing the intraoperative blood loss, postoperative complications, disease-free survival, and overall survival between the two groups of patients. Investigators expect that performing lymph node dissection according to the predictive model can lead to better prognosis for patients.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hexiao Tang, PhD; Phone Number: +86 15102723563; Email: thx1245@sina.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430071
      • Zhongnan Hospital of Wuhan University
      • Contact: Hexiao Tang, PhD; Phone Number: +86 15102723563; Email: thx1245@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age range from 18 to 70 years old;
2. Chest CT shows a single pulmonary nodule, which may be adenocarcinoma or squamous cell carcinoma;
3. Chest CT shows multiple pulmonary nodules, but preoperative evaluation suggests that pulmonary nodules other than the main lesion are benign;
4. Preoperative auxiliary examination evaluates the patient as clinically resectable lung adenocarcinoma or squamous cell carcinoma in stages I, II, or IIIA (UICC-TNM 9th edition);
5. ECOG score 0-1;
6. Preoperative lung function FEV1 ≥ 1.0L and actual/expected value ≥ 80%;
7. No contraindications for surgery;
8. Technically, lobectomy or segmental resection combined with lymph node dissection can be performed;
9. Preoperative plain scan and enhanced chest CT examination;
10. The interval between surgery and chest CT, lung function, and electrocardiogram examinations is less than or equal to 28 days;
11. The patient signs a written informed consent form.

Exclusion Criteria:

1. Chest CT suggests multiple primary lung cancer or metastatic cancer;
2. Previous history of thoracic surgery;
3. Previous history of malignant tumors;
4. History of neoadjuvant therapy;
5. A history of severe heart failure, myocardial infarction, cerebral infarction, and pneumonia within 6 months prior to surgery;
6. Concurrent active bacterial or fungal infections;
7. Severe underlying lung diseases such as interstitial lung disease, pulmonary fibrosis, or emphysema are complicated;
8. Concomitant mental illness;
9. Pregnant/lactating women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Model group; During surgery, lymph nodes predicted to be metastatic will be dissected based on the predicted results of the model.	Procedure: Lymph node dissection based on the model; During surgery, lymph nodes will be dissected based on the predicted lymph node status by the model.
Active Comparator: Guideline group; During surgery, lymph nodes will be dissected based on the NCCN guidelines (2023).	Procedure: Lymph node dissection based on the guidelines; During surgery, mediastinal lymph nodes will be dissected based on the NCCN guidelines (2023) .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consistency rate between preoperative prediction results and postoperative pathological results	Compare postoperative lymph node pathology results with preoperative prediction results	1 week after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	Observation of complications within 30 days after surgery	30 days after surgery
Postoperative recurrence rate	Observe for recurrence within 2 years after surgery	2 years after surgery
Disease-free survival	Follow up after surgery to determine if there is any recurrence or metastasis, and calculate disease-free survival	2 years after surgery
Overall survival	Follow up after surgery to determine if there is death, and calculate overall survival	2 years after surgery
Intraoperative blood loss	Record intraoperative blood loss	During the surgery
Postoperative drainage volume	Record postoperative drainage volume	2 weeks after surgery
Postoperative drainage time	Record the time from the end of the surgery to the removal of the drain tube	2 weeks after surgery

Collaborators and Investigators

• Sponsor: Zhongnan Hospital
• Investigators: Study Chair: Hexiao Tang, PhD, Zhongnan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 29, 2024
• First Submitted That Met QC Criteria: January 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: lung cancer; mediastinal lymph node
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 20240329

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
• product manufactured in and exported from the U.S.: No