As a new dual receptor (integrin αvβ3 and FAP) targeting PET radiotracer, 68Ga-FAPI-RGD is promising as an excellent imaging agent applicable to various cancers. In this research, we investigate the safety, biodistribution and radiation dosimetry of 68Ga-FAPI-RGD in healthy volunteers. Moreover, we evaluate the potential usefulness of 68Ga-FAPI-RGD positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer, and compared with 18F-FDG PET/CT.

As a new dual receptor (integrin αvβ3 and FAP) targeting PET radiotracer, 68Ga-FAPI-RGD is promising as an excellent imaging agent applicable to various cancers. In this research, we investigate the safety, biodistribution and radiation dosimetry of 68Ga-FAPI-RGD in healthy volunteers. Moreover, Subjects with various types of cancer underwent contemporaneous 68Ga-FAPI-RGD and 18F-FDG PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The numbers of positive tumor lesions of 18F-FDG and 68Ga-FAPI-RGD PET/CT were recorded by visual interpretation. The diagnostic accuracy of 68Ga-FAPI-RGD were calculated and compared to 18F-FDG PET/CT.

Inclusion Criteria:

• adult patients (aged 18 years or order);
• patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report);
• patients who had scheduled both 18F-FDG and 68Ga-FAPI-RGD PET/CT scans;
• patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

• patients with non-malignant lesions;
• patients with pregnancy;
• the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.