Radiomics in clinical trials: perspectives on standardization

Area of Science:

• Medical Imaging
• Quantitative Imaging Analysis
• Biomarker Development

Background:

• Biomarkers are crucial for understanding disease behavior and guiding clinical decisions.
• Traditional imaging biomarkers are well-established in clinical practice.
• Radiomics, a novel quantitative imaging analysis, extracts numerous features using high-throughput computing.

Purpose of the Study:

• To review the technical difficulties in clinical radiomics applications.
• To discuss current efforts in addressing these challenges within clinical trial designs.
• To highlight the potential of radiomics as a qualified biomarker.

Main Methods:

• Extraction of a large number of advanced imaging features via high-throughput computing.
• Review of existing research on radiomics for predicting disease behavior, progression, and treatment response.
• Analysis of challenges including lack of reproducibility and transparency in radiomics.

Main Results:

• Radiomics demonstrates value in predicting disease behavior, progression, and therapeutic response.
• Significant challenges hinder radiomics' clinical viability, notably reproducibility and transparency.
• The data-driven nature of radiomics currently limits biological insights.

Conclusions:

• Addressing technical and methodological challenges is crucial for clinical radiomics implementation.
• Standardization and validation efforts are necessary to establish radiomics as a reliable biomarker.
• Overcoming current limitations will unlock the full potential of radiomics in clinical decision-making.