Rethinking quantitative PET metrics in early-phase radiopharmaceutical studies
Standardized uptake values (SUVs) have long been the go-to metric for PET quantitation—but in Phase 0 clinical trials, they may be more burden than benefit. This eBook examines the technical, biological, and interpretive variability of SUV measurements and the operational complexities of harmonization frameworks such as EARL, QIBA, and UPICT.
Through a critical review of publications from 2008–2023, the authors highlight why SUVs often fail to serve as reliable endpoints in exploratory trials—and why alternative measures like qualitative uptake, volumetric assessment, and kinetic modeling may provide better alignment with the mechanistic aims of early-phase development.
You’ll learn:
The key sources of SUV variability in multicenter PET trials
Why harmonization requirements add complexity without proportional scientific gain
How non-SUV endpoints can strengthen early clinical signal detection
Practical recommendations for Phase 0 PET study design and endpoint selection
Featuring insight from two leaders in nuclear medicine and radiopharmaceutical development—Dr. Colin Miller and Dr. Alexander (Sandy) McEwan—this whitepaper bridges clinical, scientific, and regulatory perspectives to inform more efficient imaging strategies.
Gain evidence-based insights to refine your PET trial strategy and explore how Bracken’s radiopharmaceutical experts can help you optimize imaging endpoints from discovery through commercialization.
