Comparison of 68Ga-FAPI-46 PET and 18F-FDG PET in Lung Cancer

68Ga-FAPI PET in Evaluation of the Patient With Known or Suspected Lung Cancer: Comparison With Standard 18F-FDG PET

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.

Inclusion Criteria:

1. Age > 20 years
2. Informed consent obtained from patients and families
3. Patients with histology confirmed lung cancer or patients with GGO on chest CT planned to have biopsy or surgery
4. Patients scheduled to undergo FDG-PET examination
5. Performance status: 0, 1, 2, 3

Exclusion Criteria:

1. Contraindication to FAPI-PET and FDG-PET such as pregnant, or lactating patients
2. Patients with mainly malignant pleural effusion without other measurable lesions
3. Undergoing irradiation at accrual
4. Active infection or other serious underlying medical conditions not compatible with study entry
5. History of significant neurological or psychiatric disorders including dementia that would prohibit the understanding and giving of informed consent