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18F-FDG PET/CT to Evaluate pD-1 Monoclonal Antibody Combined With First-line Chemotherapy in Advanced Non-small Cell Lung Cancer

Sponsor
Wuhan Union Hospital, China (Other)
Overall Status
Recruiting
CT.gov ID
NCT04996927
Collaborator
(none)
50
Enrollment
1
Location
24
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a diagnostic study. Subjects were enrolled from clinical stage IIIB or IV NSCLC patients who received standard first-line chemotherapy combined with PD-1 monoclonal antibody immunotherapy and received 18F-FDG PET/CT imaging before treatment, after 2 courses of treatment, and at the time of disease progression.At the same time, the blood routine, liver and kidney function, inflammatory indexes and other laboratory data of the subjects participating in the study were collected. Based on 18F-FDG PET Ipercist standard and comprehensive laboratory indicators, the subjects were evaluated for tumor biological characteristics prediction and clinical staging, PD-1 immune efficacy monitoring and evaluation, tumor recurrence monitoring and re-staging. At the same time, the systemic immune response and immune-related adverse events during the treatment process were evaluated in order to establish a better evaluation standard and system for the comprehensive evaluation of PD-1 immunotherapy.This study plans to set the sample size as 50 cases.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    A Prospective, Single-arm, Observational Clinical Study Based on 18F-FDG PET/CT to Evaluate the True Efficacy and Immune Response of PD-1 Monoclonal Antibody Combined With First-line Chemotherapy in Advanced Non-small Cell Lung Cancer
    Actual Study Start Date :
    Jun 1, 2021
    Anticipated Primary Completion Date :
    Jun 1, 2022
    Anticipated Study Completion Date :
    Jun 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Sensitivity and specificity of 18F-FDG PET/CT for diagnosis the true efficacy and immune response of Non-small Cell Lung Cancer [2 years]

      PET/MR results will be compared with histopathological, clinical, laboratory, radiological evidence, and follow-up results.

    Secondary Outcome Measures

    1. Change after treatment [2 years]

      For patient after treatment, change of PET scan and clinical/radiological/histopathological indices.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Adult patients (age 18 or above), gender unlimited;

    • Pathological diagnosis of non-small cell lung cancer stage IIIB or above;

    • Agree to carry out the standard first-line chemotherapy combined with immunosuppression established in this study;

    • Consent to 18F-FDG PET/CT imaging and related laboratory examination before and during treatment;

    • The patients themselves or their legal representatives are aware of this study and can sign the informed consent.

    Exclusion Criteria:

    • Acute systemic diseases and electrolyte disturbances;

    • Pregnant or lactating women;

    • The patient or his legal representative is unable or unwilling to sign the informed consent.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 China, Hubei Province Wuhan Hubei China 430022

    Sponsors and Collaborators

    • Wuhan Union Hospital, China

    Investigators

    • Study Director: Xiaoli Lan, PhD, Wuhan Union Hospital, China

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xiaoli Lan, Director of the Department of nuclear medicine, Wuhan Union Hospital, China
    ClinicalTrials.gov Identifier:
    NCT04996927
    Other Study ID Numbers:
    • XLan-0200
    First Posted:
    Aug 9, 2021
    Last Update Posted:
    Aug 13, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Aug 13, 2021