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

Xiamen University

Status

Enrolling

Conditions

FAP

SSTR2

Positron-Emission Tomography

Treatments

Diagnostic Test: 18F-FDG PET/CT, 68Ga-FAPI-LM3 PET/CT

Study type

Interventional

Funder types

Other

Identifiers

NCT05873777

XMFHIIT-2022SL070

Details and patient eligibility

About

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.

Full description

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, subjects with SSTR2 positive diseases underwent contemporaneous 68Ga-FAPI-LM3 and 18F-FDG PET/CT for diseases assessment. Lesions uptakes were quantified by the maximum standard uptake value (SUVmax). The numbers of positive lesions of 18F-FDG and 68Ga-FAPI-LM3 PET/CT were recorded by visual interpretation. The diagnostic accuracy of 68Ga-FAPI-LM3 were calculated and compared to 18F-FDG PET/CT.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

(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.

Exclusion criteria

(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.