This is a prospective, single-center, single arm, open label study to evaluate the performance of 68Ga-FAPI-46 for the diagnosis of primary and metastatic lesions of lung cancer with comparison to 18F-FDG PET.
FDG-PET imaging is recommended by clinical guidelines for staging of lung cancer; however, there are still limitations of FDG-PET in lung cancer staging due to false-positive and false-negative findings. 68Ga-FAPI PET images have shown high diagnostic performance with high tumor-to-background ratio in various cancers. The purpose of this study is head-to-head comparison of 68Ga-FAPI-46 PET and 18F-FDG PET for the diagnosis and staging or re-staging of lung cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
58
68Ga-FAPI-46 is a radioactive diagnostic agent for PET imaging in the detection of Fibroblast Activation Protein (FAP) positive tumor cells in cancer patients
Department of Nuclear Medicine, Chang Gung Memorial Hospital
Taoyuan, Taiwan
To define the diagnostic performance 68Ga-FAPI PET
To evaluate the diagnostic performance (sensitivity, specificity, accuracy) of the 68Ga-FAPI-46 PET scan for identification and staging of lung cancer with comparison to 18F-FDG PET. Histopathology and clinical follow-up will be used as truth standard.
Time frame: Through study completion, 2 years
To determine the safety profile of 68Ga-FAPI PET
Number of participants with 68Ga-FAPI-46 PET scan related adverse events assessed by CTCAE v5.0
Time frame: Up to 7 days post injection with 68Ga-FAPI-46
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.