68Ga-FAPI-LM3 PET/CT Imaging in Patients With FAP/SSTR2 Positive Disease and Compared With 18F-FDG

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Xiamen University

About this trial

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.

Eligibility criteria

Qualifiers

(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.

Disqualifiers

(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.

Trial design

Treatments tested in this trial

  • 18F-FDG PET/CT, 68Ga-FAPI-LM3 PET/CT

Treatment groups

30 Participants
are divided into 1 treatment group