Radiomics of Immunotherapeutics Response Evaluation and Prediction

NCT04079283 | Completed DMC

• 1 other identifier: IIT0100
• Study Type: observational
• Target: 285
• Locations: 1 country
• Sites: 1

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 predicting the response of immunotherapeutics. A multi-center retrospective diagnostic test has been designed for this aim to compare the predictive performance of clinical model, qualitative model incorporating semantic CT features and image-based quantitative radiomic model. The reference standard of therapeutic effect is determined by the latest evaluation result utilizing iRECIST within 365 days after recruited. This study intends to enroll 400 participates who had been diagnosed with advanced somatic solid tumor confirmed by histo- or cyto-pathological examination and were planning to receive immunotherapy.

Conditions

Solid Tumor; Predictive Cancer Model

Keywords

Response Evaluation Criteria in Solid Tumors; Computed Tomography; Radiomics; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Area Under the receiver operating characteristic curve (ROC)

  Area under curve (AUC) of each diagnostic model

  6 months and 1 year since course start (365 days)

Secondary Outcomes (2)

• Disease Control Rate

  6 months and 1 year since course start (365 days)

• Incidence

  Through study completion, an average of 1 year

Study Arms (2)

Monotherapy

Patients who has received mono-therapy of immune checkpoint inhibitor.

Diagnostic Test: Clinical; Diagnostic Test: Semantic; Diagnostic Test: Radiomic

Combined therapy

Patients who has received immune checkpoint inhibitor combining chemotherapy.

Diagnostic Test: Clinical; Diagnostic Test: Semantic; Diagnostic Test: Radiomic

Interventions

Clinical DIAGNOSTIC_TEST

Clinical: A diagnostic model incorporating clinical variables (Age, Pathological diagnosis, level of serum tumor biomarkers etc.)

Combined therapy; Monotherapy

Semantic DIAGNOSTIC_TEST

Semantic: A diagnostic model incorporating semantic radiological features (shape, location, border, density etc.)

Also known as: Radiological

Combined therapy; Monotherapy

Radiomic DIAGNOSTIC_TEST

Radiomic: A diagnostic model incorporating quantitative radiomic features (histogram, texture, morphology etc.)

Combined therapy; Monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inpatient records in each involved research center from 2017.01.01 to 2019.12.31.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead
• Tianjin Chest Hospital: collaborator
• Shandong Tumor Hospital: collaborator
• West China Hospital: collaborator
• First Affiliated Hospital of Zhejiang University: collaborator
• Sun Yat-sen University: collaborator
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator
• Liaoning Cancer Hospital & Institute: collaborator
• Hubei Cancer Hospital: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator

Study Sites (1)

Tianjin Medical University Cancer Institute And Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

MeSH Terms

Interventions

Latent Class Analysis; Postmortem Imaging; Radiomics

Intervention Hierarchy (Ancestors)

Cluster Analysis; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Algorithms; Mathematical Concepts; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Autopsy; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging

Study Officials

• Zhaoxiang Ye, M.D, Ph.D

  Tianjin Medical University Cancer Institute and Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2019
• First Posted: September 6, 2019
• Study Start: January 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: February 25, 2020
• Last Updated: April 2, 2020

Record last verified: 2019-06

Locations

CN (1)