Status:
COMPLETED
Radiomics of Immunotherapeutics Response Evaluation and Prediction
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Collaborating Sponsors:
Tianjin Chest Hospital
Shandong Tumor Hospital
Conditions:
Solid Tumor
Predictive Cancer Model
Eligibility:
All Genders
18+ years
Brief Summary
This study aims to investigate the feasibility and efficiency of CT radiomic analysis which serves as a high through-put analytical strategy applied to image big-data resource in evaluating and predic...
Eligibility Criteria
Inclusion
- Patients with histopathological or cytopathological confirmed solid tumor (including metastatic solid tumor).
- Patients ≥ 18 years of age on the day of baseline CT scan.
- Patients received immune checkpoint inhibitors (ICI) monotherapy or combined with chemotherapy in any line of treatment.
- Patients with at least one measurable target lesion of which minor axis was greater than 15mm and without any local treatment.
- Female with a negative pregnancy test, or male who agree to use barrier methods of contraception through the therapy period.
- Patients with a Eastern Cooperative Oncology Group(ECOG) performance status score of 0 or 1.
- Patients underwent follow-up CT scans with an 6-9-week interval until 365 days after baseline CT scan.
- 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
- Patients received any kinds of cytotoxic drugs or experimental drugs 2 weeks before enrollment.
- Patients meet the contraindications of contrast-enhanced CT scan.
- Patients who were not suitable for continuous follow-up CT scans.
- 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.
- Patients who cannot tolerate immunotherapy or with serious immune-related adverse response.
- Patients with severe interstitial pneumonia confirmed by baseline CT scan.
- Patients who cannot complete follow-up examinations scheduled by study design.
- Patients with AIDS or positive serum HIV antibodies.
- Patients with a CT scan presenting extremely low signal noise ratio or too much artifacts at any timepoint.
Key Trial Info
Start Date :
January 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 25 2020
Estimated Enrollment :
285 Patients enrolled
Trial Details
Trial ID
NCT04079283
Start Date
January 1 2017
End Date
February 25 2020
Last Update
April 2 2020
Active Locations (1)
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1
Tianjin Medical University Cancer Institute And Hospital
Tianjin, Tianjin Municipality, China, 300060