Skip to main content
OpenTrials
Completed

NCT Number: NCT04079283

Radiomics of Immunotherapeutics Response Evaluation and Prediction

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Solid Tumor Predictive Cancer Model

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tianjin Medical University Cancer Institute And Hospital

Tianjin, Tianjin Municipality, 300060, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Clinical

Diagnostic Test

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

Semantic

Diagnostic Test

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

Other names: Radiological

Radiomic

Diagnostic Test

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

Primary outcomes

  1. Area Under the receiver operating characteristic curve (ROC)

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

    Area under curve (AUC) of each diagnostic model

Secondary outcomes

  1. Disease Control Rate

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

    Disease Control Rate of immunotherapy

  2. Incidence

    Time frame: Through study completion, an average of 1 year

    Incidence of immune-related adverse events

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: RIREP

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Sep 6, 2019
Registry last updated
Apr 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.