PET-CT Predicting Segement Specific Lymph Nodes Metastasis

Recruiting

• Conditions: Lymph Node Metastasis; Positron Emission Tomography; Non Small Cell Lung Cancer

• Registration Number: NCT05970913
• Lead Sponsor: Fudan University

Brief Summary

This study is a multicenter prospective clinical study that aims to evaluate the predictive value of preoperative PET-CT results (such as SUV uptake, size of tumor lymph nodes, and differences in FDG uptake compared to surrounding tissues) for lymph node metastasis in patients with non-small cell lung cancer. During surgery, all patients underwent systematic mediastinal lymph node dissection. The final pathological results were used to assess the predictive value of PET-CT for segment-specific lymph node metastasis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-23
• Study First Submitted QC: 2023-07-23
• Study First Posted: 2023-08-01
• Study Start: 2023-11-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-19
• Primary Completion: 2024-11-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

• Solitary tumor, or multiple tumors with only ground-glass nodules (GGNs) apart from the primary lesion.
• Diameter of the primary lesion ≤5cm, with a CTR between 0.5 and 1.
• No enlarged mediastinal lymph nodes observed on preoperative contrast-enhanced CT.
• Pathological confirmation of non-small cell lung cancer (NSCLC) either before or during surgery.
• Systematic lymph node dissection performed during surgery.
• No prior radiotherapy or chemotherapy for initial treatment.
• No history of malignant tumors.

Exclusion Criteria

• Locally advanced or distant metastasis.
• Pleural dissemination observed during surgery.
• History of malignant tumors.
• Received neoadjuvant therapy.
• Systematic lymph node dissection not performed during surgery.
• Histopathological examination reveals lung malignancies other than non-small cell lung cancer (NSCLC).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Predictive value of PET-CT for segment-specific lymph node metastasis	Preoperative

Trial Locations

Locations (1)

Shanghai Cancer Center; 🇨🇳 Shanghai, China