RecruitingNot ApplicableNCT05873777

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


Sponsor

The First Affiliated Hospital of Xiamen University

Enrollment

30 participants

Start Date

Apr 9, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria4

  • (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 Criteria3

  • (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.

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Interventions

DIAGNOSTIC_TEST18F-FDG PET/CT, 68Ga-FAPI-LM3 PET/CT

Each 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.


Locations(1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

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NCT05873777


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