Radiomics of Immunotherapeutics Response Evaluation and Prediction
NCT ID: NCT04079283
Last Updated: 2020-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
285 participants
OBSERVATIONAL
2017-01-01
2020-02-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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Monotherapy
Patients who has received mono-therapy of immune checkpoint inhibitor.
Clinical
Clinical: A diagnostic model incorporating clinical variables (Age, Pathological diagnosis, level of serum tumor biomarkers etc.)
Semantic
Semantic: A diagnostic model incorporating semantic radiological features (shape, location, border, density etc.)
Radiomic
Radiomic: A diagnostic model incorporating quantitative radiomic features (histogram, texture, morphology etc.)
Combined therapy
Patients who has received immune checkpoint inhibitor combining chemotherapy.
Clinical
Clinical: A diagnostic model incorporating clinical variables (Age, Pathological diagnosis, level of serum tumor biomarkers etc.)
Semantic
Semantic: A diagnostic model incorporating semantic radiological features (shape, location, border, density etc.)
Radiomic
Radiomic: A diagnostic model incorporating quantitative radiomic features (histogram, texture, morphology etc.)
Interventions
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Clinical
Clinical: A diagnostic model incorporating clinical variables (Age, Pathological diagnosis, level of serum tumor biomarkers etc.)
Semantic
Semantic: A diagnostic model incorporating semantic radiological features (shape, location, border, density etc.)
Radiomic
Radiomic: A diagnostic model incorporating quantitative radiomic features (histogram, texture, morphology etc.)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients ≥ 18 years of age on the day of baseline CT scan.
3. Patients received immune checkpoint inhibitors (ICI) monotherapy or combined with chemotherapy in any line of treatment.
4. Patients with at least one measurable target lesion of which minor axis was greater than 15mm and without any local treatment.
5. Female with a negative pregnancy test, or male who agree to use barrier methods of contraception through the therapy period.
6. Patients with a Eastern Cooperative Oncology Group(ECOG) performance status score of 0 or 1.
7. Patients underwent follow-up CT scans with an 6-9-week interval until 365 days after baseline CT scan.
8. Patients with baseline and follow-up CT scans which meet the following conditions: a) Spiral computed tomography device of General Electric Healthcare or Siemens with greater than 16 rows of detectors ; b) Peak kilovoltage: 120kV; c) Dose: auto or fixed; d) Slice resolution: not less than 512 pixels multiply 512 pixels; e) Scanning range: from supraclavicular region to 2cm below the costophrenic angle for thorax, and from diaphragm to pubic symphysis for abdomen; f) contrast-enhanced scan utilizing nonionic low- or iso-osmolar contrast agent and including arterial phase, venous phase and delayed phase at least.
Exclusion Criteria
2. Patients meet the contraindications of contrast-enhanced CT scan.
3. Patients who were not suitable for continuous follow-up CT scans.
4. Patients with severe myocardial infarction confirmed by ECG or left ventricular ejection fraction(LVEF) less than 40% or glomerular filtration rate(GFR) less than 45ml/min.
5. Patients who cannot tolerate immunotherapy or with serious immune-related adverse response.
6. Patients with severe interstitial pneumonia confirmed by baseline CT scan.
7. Patients who cannot complete follow-up examinations scheduled by study design.
8. Patients with AIDS or positive serum HIV antibodies.
9. Patients with a CT scan presenting extremely low signal noise ratio or too much artifacts at any timepoint.
18 Years
ALL
No
Sponsors
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Tianjin Chest Hospital
OTHER
Shandong Tumor Hospital
OTHER
West China Hospital
OTHER
First Affiliated Hospital of Zhejiang University
OTHER
Sun Yat-sen University
OTHER
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Liaoning Cancer Hospital & Institute
OTHER
Hubei Cancer Hospital
OTHER
First Affiliated Hospital Xi'an Jiaotong University
OTHER
Tianjin Medical University Cancer Institute and Hospital
OTHER
Responsible Party
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Principal Investigators
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Zhaoxiang Ye, M.D, Ph.D
Role: STUDY_CHAIR
Tianjin Medical University Cancer Institute and Hospital
Locations
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Tianjin Medical University Cancer Institute And Hospital
Tianjin, Tianjin Municipality, China
Countries
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Other Identifiers
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IIT0100
Identifier Type: -
Identifier Source: org_study_id
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