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NCT Number: NCT05873777

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Diagnostic Test

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.

Primary outcomes

  1. Diagnostic efficacy

    Time frame: 30 days

    The sensitivity, specificity, and accuracy of 18F-FDG and 68Ga-FAPI-LM3 PET/CT were calculated and compared to evaluate the diagnostic accuracy

Secondary outcomes

  1. SUV

    Time frame: 2 days

    Standardized uptake value (SUV) of 18F-FDG and 68Ga-FAPI-LM3 PET/CT for each positive lesion of subject.

  2. Number of lesions

    Time frame: 2 days

    The numbers of positive lesions of 18F-FDG and 68Ga-FAPI-LM3 PET/CT were recorded by visual interpretation.

Study contacts

Contact information is provided by the study sponsor or research team.

Long Sun, PhD

CONTACT

[email protected]

86 0592-2137077

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Xiamen University

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 24, 2023
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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