NCT04079283

Radiomics of Immunotherapeutics Response Evaluation and Prediction

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 285 (actual)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2017-01-01
• Primary completion: 2019-12-31
• Completion: 2020-02-25
• First posted: 2019-09-06
• Last updated: 2020-04-02

Locations

1 site across 1 country: China