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NCT05970913 Clinical Trial

PET-CT Predicting Segement Specific Lymph Nodes Metastasis

Non Small Cell Lung Cancer Clinical Trial

Official title:
The Value of PET-CT in Predicting Segement Specific Lymph Nodes Metastasis in Non Small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05970913
Other study ID # ECTOP-1017
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2023
Est. completion date December 1, 2024

Study information
Verified date October 2023
Source Fudan University
Contact Hang Li
Phone +862164175590
Email drlihang@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 280
Est. completion date December 1, 2024
Est. primary completion date November 1, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
China Shanghai Cancer Center Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Predictive value of PET-CT for segment-specific lymph node metastasis Preoperative
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