Radiomics of Immunotherapeutics Response Evaluation and Prediction (RIREP)

Radiomics of Immunotherapeutics Response Evaluation and Prediction in Solid Tumor: A Multicenter Diagnostic Study

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.

Study Overview

• Status: Completed
• Conditions: Solid Tumor; Predictive Cancer Model
• Intervention / Treatment: Diagnostic test: Clinical; Diagnostic test: Semantic; Diagnostic test: Radiomic

• Study Type: Observational
• Enrollment (Actual): 285

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Tianjin Medical University Cancer Institute and Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. Patients with histopathological or cytopathological confirmed solid tumor (including metastatic solid tumor).
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:

1. Patients received any kinds of cytotoxic drugs or experimental drugs 2 weeks before enrollment.
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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Monotherapy; Patients who has received mono-therapy of immune checkpoint inhibitor.	Diagnostic test: Clinical; Clinical: A diagnostic model incorporating clinical variables (Age, Pathological diagnosis, level of serum tumor biomarkers etc.); Diagnostic test: Semantic; Semantic: A diagnostic model incorporating semantic radiological features (shape, location, border, density etc.); Other Names: Radiological; Diagnostic test: Radiomic; Radiomic: A diagnostic model incorporating quantitative radiomic features (histogram, texture, morphology etc.)
Combined therapy; Patients who has received immune checkpoint inhibitor combining chemotherapy.	Diagnostic test: Clinical; Clinical: A diagnostic model incorporating clinical variables (Age, Pathological diagnosis, level of serum tumor biomarkers etc.); Diagnostic test: Semantic; Semantic: A diagnostic model incorporating semantic radiological features (shape, location, border, density etc.); Other Names: Radiological; Diagnostic test: Radiomic; Radiomic: A diagnostic model incorporating quantitative radiomic features (histogram, texture, morphology etc.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Control Rate	Disease Control Rate of immunotherapy	6 months and 1 year since course start (365 days)
Incidence	Incidence of immune-related adverse events	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Collaborators: Sun Yat-sen University; Cancer Institute and Hospital, Chinese Academy of Medical Sciences; West China Hospital; Hubei Cancer Hospital; First Affiliated Hospital Xi'an Jiaotong University; First Affiliated Hospital of Zhejiang University; Liaoning Tumor Hospital & Institute; Tianjin Chest Hospital; Shandong Tumor Hospital
• Investigators: Study Chair: Zhaoxiang Ye, M.D, Ph.D, Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): February 25, 2020

Study Registration Dates

• First Submitted: September 1, 2019
• First Submitted That Met QC Criteria: September 4, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): April 2, 2020
• Last Update Submitted That Met QC Criteria: March 31, 2020
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Immunotherapy; Computed Tomography; Radiomics; Response Evaluation Criteria in Solid Tumors
• Other Study ID Numbers: IIT0100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes