Radiomic and Volumetric Measurements as Clinical Trial Endpoints-A Comprehensive Review

Area of Science:

• Oncology
• Radiology
• Biomarkers

Background:

• Current oncology drug development relies on surrogate biomarkers like RECIST v1.1, assessing tumor burden changes.
• Tumor size reduction is an imperfect surrogate for drug activity, yet objective response rate is a common Phase 2 endpoint.
• Novel therapies targeting complex biological systems necessitate integrative response and outcome biomarkers.

Purpose of the Study:

• To review the literature on volumetric and radiomics metrics for oncology clinical trial endpoints.
• To assess the readiness of these advanced metrics across four tumor types: breast cancer, rectal cancer, lung cancer, and glioblastoma.
• To identify key areas for development to enable wider clinical implementation.

Main Methods:

• Literature review focusing on volumetric and radiomics metrics in oncology.
• Analysis of preparedness for these metrics as clinical trial endpoints in representative tumor types.
• Identification of critical development areas including segmentation, validation, and data sharing.

Main Results:

• Volumetric and radiomics metrics offer potential for more predictive endpoints in oncology trials.
• The current literature review highlights the need for standardization in these advanced imaging techniques.
• Three critical areas require concerted efforts: segmentation, validation, and data sharing strategies.

Conclusions:

• Volumetric and radiomics metrics hold significant potential to enhance oncology clinical trial endpoints.
• Standardization in segmentation, validation, and data sharing is essential for the clinical implementation of these metrics.
• Addressing these key areas will facilitate the progress of volumetric and radiomics-based endpoints for broader clinical use.