Clinical ⁶⁸Ga-PET: Is radiosynthesis module an absolute necessity?

Area of Science:

• Nuclear Medicine
• Radiopharmacy
• Positron Emission Tomography (PET)

Background:

• Commercially available ⁶⁸Ge/⁶⁸Ga generators typically require automated synthesis modules for ⁶⁸Ga radiopharmaceutical production.
• High costs associated with these modules limit the global accessibility of ⁶⁸Ga-based PET imaging.
• Developing module-free synthesis strategies is crucial for broader clinical adoption and affordability.

Purpose of the Study:

• To evaluate an organic matrix-based ⁶⁸Ge/⁶⁸Ga generator for producing ⁶⁸Ga radiopharmaceuticals without automated synthesis modules.
• To assess the feasibility of direct elution and radiolabeling in a clinical radiopharmacy setting.
• To determine the clinical utility and cost-effectiveness of this simplified approach.

Main Methods:

• Utilized an organic matrix ⁶⁸Ge/⁶⁸Ga generator for preparing four key ⁶⁸Ga radiopharmaceuticals: ⁶⁸Ga-DOTA-NOC, ⁶⁸Ga-NODAGA-RGD₂, ⁶⁸Ga-PSMA-11, and ⁶⁸Ga-BPAMD.
• Optimized radiolabeling conditions for direct use of eluted ⁶⁸Ga, bypassing synthesis modules.
• Conducted comprehensive performance evaluations over nine months, including quality control tests and clinical PET scans in patients.

Main Results:

• The generator consistently provided ⁶⁸Ga with high elution yields (60-85%) and excellent radionuclidic purity (>99.99%).
• Module-free synthesis yielded ⁶⁸Ga radiopharmaceuticals with high radiochemical purity (>95%), meeting clinical administration standards.
• PET scans confirmed the clinical efficacy, and over 100 doses were prepared reproducibly over nine months.

Conclusions:

• This module-free method significantly enhances the practicality and cost-effectiveness of clinical ⁶⁸Ga radiopharmacy.
• This represents a pioneering approach for clinical-scale synthesis and application of ⁶⁸Ga radiopharmaceuticals without specialized synthesis modules.
• The findings pave the way for wider and more affordable ⁶⁸Ga-PET imaging globally.