Clinical trial NCT03648151: Influence of PET/CT Radiomic Features on the Outcome of Lung Cancer Patients
Official title: Influence of PET/CT Radiomic Features on the Outcome of Lung Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Image, Body
Keywords: Radomic feature
PET
CT
Lead sponsor: The First Affiliated Hospital of Shanxi Medical University
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Anhui Medical University
First posted: 2018-08-27
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: lung caner

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival (OS) of lung cancer patients
timeFrame: The patients were followed to December 31, 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Taiyuan
country: China
facility: First Affiliated Hospital of Shanxi Medical University
state: Shanxi
Study officials:
affiliation: First Affiliated Hospital of Shanxi Medical University
name: Li Sijin, MD
role: STUDY_CHAIR
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