As a new dual receptor (SSTR2 and FAP) targeting PET radiotracer, 68Ga-FAPI-LM3 is promising as an excellent imaging agent applicable to SSTR2 positive diseases. In this research, we investigate the safety, biodistribution and radiation dosimetry of 68Ga-FAPI-LM3 in healthy volunteers. Moreover, we evaluate the potential usefulness of 68Ga-FAPI-LM3 positron emission tomography/computed tomography (PET/CT) for the diagnosis of lesions in SSTR2 positive diseases, and compared with 18F-FDG PET/CT.
(i) adult patients (aged 18 years or order);
(ii) patients with suspected or newly diagnosed or previously malignant disease, with either FAP or SSTR2 positive expression (supporting evidence may include MRI, CT, and pathology report etc);
(iii) patients who had scheduled both 18F-FDG and 68Ga-FAPI-LM3 PET/CT scans;
(iv) 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.
(i) patients with non-malignant disease;
(ii) patients with pregnancy;
(iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Single group
18F-FDG PET/CT, 68Ga-FAPI-LM3 PET/CT
Diagnostic testEach subject receives a single intravenous injection of 18F-FDG and 68Ga-FAP-LM3, and undergo PET/CT imaging within the specified time. A part of participants will undergo additional 68Ga-FAPI-46 PET/CT for comparison.
Diagnostic efficacy
The sensitivity, specificity, and accuracy of 18F-FDG and 68Ga-FAPI-LM3 PET/CT were calculated and compared to evaluate the diagnostic accuracy
SUV
Standardized uptake value (SUV) of 18F-FDG and 68Ga-FAPI-LM3 PET/CT for each positive lesion of subject.
Number of lesions
The numbers of positive lesions of 18F-FDG and 68Ga-FAPI-LM3 PET/CT were recorded by visual interpretation.
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