Imaging endpoints for clinical trial use: a RECIST perspective

Area of Science:

• Oncology
• Radiology
• Clinical Trials

Background:

• Response Evaluation Criteria in Solid Tumors (RECIST) has been the standard for over 20 years.
• No alternative criteria have achieved RECIST's widespread adoption.
• Oncology's rapid evolution presents challenges to RECIST's continued utility.

Purpose of the Study:

• To review challenges facing RECIST in modern oncology.
• To discuss the integration of new imaging modalities like PET scans.
• To explore validation requirements for new imaging endpoints in clinical trials.

Main Methods:

• Review of current RECIST application and limitations.
• Discussion of emerging imaging technologies and their integration.
• Analysis of validation processes for novel clinical trial endpoints.

Main Results:

• RECIST remains the primary tool for objective tumor response assessment.
• Incorporating PET imaging and validating criteria for immunotherapeutics present significant challenges.
• Data sharing is crucial for validating new imaging endpoints.

Conclusions:

• RECIST continues to be a cornerstone in solid tumor clinical trials.
• Addressing challenges in imaging and immunotherapeutics is essential for future updates.
• A clear, repeatable, and objective standard for response assessment is paramount.