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PET-CT Predicting Segement Specific Lymph Nodes Metastasis

Sponsor
Fudan University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05970913
Collaborator
(none)
280
Enrollment
1
Location
14
Anticipated Duration (Months)
20
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    280 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Value of PET-CT in Predicting Segement Specific Lymph Nodes Metastasis in Non Small Cell Lung Cancer
    Anticipated Study Start Date :
    Aug 1, 2023
    Anticipated Primary Completion Date :
    Aug 1, 2024
    Anticipated Study Completion Date :
    Oct 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Predictive value of PET-CT for segment-specific lymph node metastasis [Preoperative]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanghai Cancer Center Shanghai China

    Sponsors and Collaborators

    • Fudan University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Haiquan Chen, Chief of the MDT board of thoracic cancer, Fudan University
    ClinicalTrials.gov Identifier:
    NCT05970913
    Other Study ID Numbers:
    • ECTOP-1017
    First Posted:
    Aug 1, 2023
    Last Update Posted:
    Aug 1, 2023
    Last Verified:
    Jul 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Neoplasm Metastasis
    Lymphatic Metastasis

    Study Results

    No Results Posted as of Aug 1, 2023