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New Method to Differentiate Benign and Malignant Pulmonary Nodules.

Sponsor
China-Japan Friendship Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06056999
Collaborator
(none)
150
Enrollment
21.3
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The goal of this observational clinical trial is to establish a new method for differentiating benign and malignant pulmonary nodules by peripheral blood detection in patients with pulmonary nodules (<3cm). The main questions it aims to answer is: How to combine blood metabolomic mass spectrometry detection and artificial intelligence image analysis to establish a new model for differentiating benign and malignant pulmonary nodules. Participants will be asked provide 4 mL peripheral blood for the test.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The aim of this clinical trial is to establish a new method for differentiating benign and malignant pulmonary nodules by the combination of metabolomics analysis and artificial intelligence (AI) analysis. It is expected to improve the accuracy of the identification of benign and malignant pulmonary nodules. Patients with clinical suspected malignant pulmonary nodules will be included in this trial. The subjects will be divided into three group by CT image presentation: (1) pure ground-glass nodule (pGGN), (2) part-solid nodule (PSN), (3) solid nodule (SN). Peripheral blood of subjects will be collected and detected by mass spectrometry to obtain the metabolomic characterization. The classification model of each group will be constructed based on the data analysis algorithm by machine learning. The diagnostic efficacy of the new model combined with the AI image analysis system for differentiating benign and malignant pulmonary nodules will be analyzed.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A New Method to Differentiate Benign and Malignant Pulmonary Nodules by Mass Spectrometry Combined With Artificial Intelligence.
    Anticipated Study Start Date :
    Sep 22, 2023
    Anticipated Primary Completion Date :
    Jan 1, 2025
    Anticipated Study Completion Date :
    Jul 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    A. pure ground-glass nodule

    Patients with pure ground-glass nodules (GGNs).
    B. part-solid nodule

    Patients with part-solid nodules (PSNs).
    C. solid nodule

    Patients with solid nodules (SNs).

    Outcome Measures

    Primary Outcome Measures

    1. Establish an model for differentiating lung nodules. [6 months]

      To establish a new method for differentiating benign and malignant pulmonary nodules by the combination of metabolomics analysis and artificial intelligence (AI) image analysis.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age ≥18 years;

    • CT imaging shows the presence of pulmonary nodule <3cm which is scheduled for puncture biopsy or surgery (i.e., the target lesion), the presence of ≥2 target lesions of the same type (categorized by density) are allowed;

    • Subjects are in good condition with Eastern Cooperative Oncology Group (ECOG) scale of 0-2;

    • Subjects with fair vital organ function, defined as: white blood cells ≥3.0×109/L, platelets ≥75×109/L, hemoglobin ≥90g/L, alanine aminotransferase and aspartate aminotransferase ≤2.5 times the upper limit of normal values, and serum creatinine <178μmol/L;

    • Subjects must have the ability to understand and sign the informed consent in writing voluntarily.

    Exclusion Criteria:

    • Imaging examination have suggested the possibility of metastasis at other sites;

    • ≥2 target lesions with different type categorized by density;

    • History of malignant disease;

    • Severe vascular lesions within the last 3 months, or known significant active infection, during acute/chronic tuberculosis infection, or severe cardiovascular and cerebrovascular diseases, dysfunction of liver and renal, or significant endocrine and metabolic disorders, or other serious concomitant diseases that are not controlled;

    • The specialist/surgeon assessed that puncture or surgery is not available, with contraindication such as coagulation disorders, cardiorespiratory insufficiency, etc.;

    • History of uncontrolled epilepsy, central nervous system disease, or psychiatric disorders, that may affect the signing of informed consent;

    • Pregnant or breastfeeding women;

    • Other conditions deemed by the investigator to be unsuitable for enrollment.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • China-Japan Friendship Hospital

    Investigators

    • Principal Investigator: Guangying Zhu, China-Japan Friendship Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Guangying Zhu, chief physician, China-Japan Friendship Hospital
    ClinicalTrials.gov Identifier:
    NCT06056999
    Other Study ID Numbers:
    • 2023-KY-0277
    • 2023-NHLHCRF-YYPPLC-ZR-02
    First Posted:
    Sep 28, 2023
    Last Update Posted:
    Sep 28, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Guangying Zhu, chief physician, China-Japan Friendship Hospital
    differential diagnosis
    benign and malignant pulmonary nodules
    early diagnosis of lung cancer
    Additional relevant MeSH terms:
    Multiple Pulmonary Nodules

    Study Results

    No Results Posted as of Sep 28, 2023