Bridging Research and Clinical Practice: Automated [⁶⁸Ga]Ga-FAPi-46 Synthesis and Quality Control for Oncological PET...

Area of Science:

• Nuclear Medicine
• Radiopharmacy
• Oncologic Imaging

Background:

• Fibroblast activation protein (FAP) is a promising target for cancer imaging.
• [68Ga]Ga-FAPi-46 demonstrates rapid tumor uptake and broad applicability.
• This study focuses on translating [68Ga]Ga-FAPi-46 to routine clinical practice.

Purpose of the Study:

• To report the automated synthesis and clinical translation of [68Ga]Ga-FAPi-46.
• To detail quality control, radiochemical stability, and initial clinical imaging results.
• To evaluate the performance of [68Ga]Ga-FAPi-46 PET/CT in a lung cancer patient.

Main Methods:

• Automated radiolabeling of FAPi-46 with Gallium-68.
• Comprehensive quality control including purity, sterility, and endotoxin testing.
• In vitro characterization and stability studies in saline and human serum.
• Clinical comparison with [18F]FDG PET/CT in a lung adenocarcinoma patient.

Main Results:

• Automated synthesis yielded high radiochemical yield (>87%) and purity (>98%).
• All batches met release specifications; radiotracer was stable in saline and serum.
• [68Ga]Ga-FAPi-46 PET/CT showed superior lesion delineation versus [18F]FDG, identifying additional metastases.

Conclusions:

• [68Ga]Ga-FAPi-46 can be reliably produced under routine radiopharmacy conditions.
• The radiotracer exhibits excellent stability and meets quality standards.
• Enhanced lesion detectability suggests value for oncologic staging and clinical implementation.