Standardization of PET/CT Performance Requirements for Whole-Body Quantitative Imaging: An International Proposal

Area of Science:

• Nuclear Medicine
• Medical Imaging Physics
• Clinical Trials Methodology

Background:

• Current Positron Emission Tomography (PET) scanner validation lacks standardization, leading to inefficiencies and repeated testing for clinical trials.
• Existing validation programs by EARL, SNMMI CTN, and ANZSNM present opportunities for harmonization.

Purpose of the Study:

• To propose a standardized PET scanner validation paradigm for clinical trials.
• To identify critical quantitative performance characteristics for PET scanners in clinical settings.

Main Methods:

• Reviewed existing PET scanner validation programs (EARL, SNMMI CTN, ANZSNM) to identify commonalities and differences.
• Identified key PET criteria for quantitative performance relevant to clinical trials.
• Recommended standardized phantom-based measurement methodologies for calibration and recovery coefficients.

Main Results:

• Developed standardized phantom requirements, acquisition protocols, reconstruction methods, analysis techniques, and acceptance criteria.
• Proposed a validation program based on radionuclide-specific calibration and harmonized recovery coefficient performance.
• Recommended quarterly 18F calibration verification (±5% accuracy) and annual verification for other radionuclides (±10% accuracy).

Conclusions:

• An internationally standardized PET scanner validation paradigm is proposed for clinical trials.
• Adoption of this system would enhance efficiency, robustness, and trustworthiness in PET scanner validation.
• Implementation is expected to decrease costs and eliminate redundant testing in clinical trials.