Considerations for generic oncology FDG-PET/CT protocol preparation in drug development

Area of Science:

• Nuclear medicine and molecular imaging
• Radiopharmaceutical imaging in oncology

Background:

• [18F]Fluorodeoxyglucose (FDG)-PET/CT is a vital imaging modality in oncology clinical trials.
• Standardization and harmonization efforts for FDG-PET/CT protocols are advancing.
• Gaps in guidance persist for optimal application in drug development.

Purpose of the Study:

• To review current applications of FDG-PET/CT in oncology clinical trials.
• To identify areas needing further standardization and expert guidance.
• To enhance the precision of FDG-PET/CT in oncological drug development.

Main Methods:

• Literature review of FDG-PET/CT applications in clinical trials.
• Analysis of current standardization efforts and remaining challenges.
• Focus on image analysis and response classification aspects.

Main Results:

• Significant progress has been made in standardizing FDG-PET/CT acquisition and analysis.
• Specific areas, particularly image analysis and response classification, require further development.
• Optimizing protocols will improve decision-making in drug development.

Conclusions:

• Standardized FDG-PET/CT protocols are essential for efficient oncology drug development.
• Further research and expert consensus are needed to address current limitations.
• Enhanced standardization will improve the reliability and precision of FDG-PET/CT imaging.