Influence of PET/CT Radiomic Features on the Outcome of Lung Cancer Patients

Sponsor
The First Affiliated Hospital of Shanxi Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT03648151
Collaborator
The First Affiliated Hospital of Anhui Medical University (Other)
1,000
2
120
500
4.2

Study Details

Study Description

Brief Summary

Radiomics is an attractive field in objectively quantifying image features, and may overcome the subjectivity of visually interpreting computed tomography (CT), or positron emission tomography (PET). It is reported that the features related to treatment response, outcomes, tumor staging, tissue identification, and cancer genetics. Therefore, the investigators try to explore the key features for the outcome of lung cancer patients.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Radiomic Features:

    PET/CT images, including other kinds of CT serials, were transported into a personal computer. Using the open source software of 3D-Slicer, volumes of interest (VOIs) for primary tumor, or even lymph nodes, was semi-automatically or manually segmented. And then, radiomic features were extracted.

    PET Parameters:

    Using combined CT VOIs, corresponding PET standard uptake value (SUV, no unit) were measured. For a foci (either tumor, or lymph node), mean, sum and maximum SUV were documented, and were used for training and validating models alongside radiomic features.

    Feature Selection:

    Data were analyzed by deep learning or random forests method, and top 20 variables were scored by their contribution to the regression (variable importance, VIMP). The generalized features were identified as the same ones between two kinds of image serials (for example, ordinary and thin-section CT, or PET and CT). Additionally, when three or more features met the criterion, a lower value of Akaike information criterion (AIC) which measures the relative quality of statistical models was used to find appropriate features with lower overfitting possibility.

    Model Validation:

    The developed model was validated internally and externally. The internal indices for independent continuous variable were accuracy (bias and absolute bias) and precision (correlation coefficient and R square), and that for independent classified or survival variable was c-index. The patients enrolled from another medical center were used for external validation.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Influence of PET/CT Radiomic Features on the Outcome of Lung Cancer Patients
    Actual Study Start Date :
    Jan 1, 2010
    Actual Primary Completion Date :
    Dec 31, 2019
    Actual Study Completion Date :
    Dec 31, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival (OS) of lung cancer patients [The patients were followed to December 31, 2019]

      The time from the scan date to death for any reason

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Pathologically diagnosed as lung caner.

    2. Accepted PET/CT scans at the hospitals either affiliated to Shanxi Medical University or Anhui Medical University

    3. Both PET and CT serials can be obtained

    4. Can be followed for treatment modalities (including chemotherapy regimens, radiotherapy dose, and et al), survival time and status, and other related information.

    Exclusion Criteria:
    1. Simultaneously suffering from the cancers from other tissues and organs

    2. Have a history of diabetes, chronic heart diseases, or chronic renal failure

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 First Affiliated Hospital of Anhui Medical University Hefei Anhui China 230022
    2 First Affiliated Hospital of Shanxi Medical University Taiyuan Shanxi China 030001

    Sponsors and Collaborators

    • The First Affiliated Hospital of Shanxi Medical University
    • The First Affiliated Hospital of Anhui Medical University

    Investigators

    • Study Chair: Li Sijin, MD, First Affiliated Hospital of Shanxi Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Hongwei Si, Chief physician, The First Affiliated Hospital of Shanxi Medical University
    ClinicalTrials.gov Identifier:
    NCT03648151
    Other Study ID Numbers:
    • 20170501
    First Posted:
    Aug 27, 2018
    Last Update Posted:
    Jul 23, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hongwei Si, Chief physician, The First Affiliated Hospital of Shanxi Medical University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 23, 2020