NCT05873777

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 9, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 16, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

August 8, 2025

Status Verified

May 1, 2025

Enrollment Period

2.7 years

First QC Date

May 16, 2023

Last Update Submit

August 5, 2025

Conditions

SSTR2FAPPositron-Emission Tomography

Keywords

SSTR2FAPPositron-Emission Tomography

Outcome Measures

Primary Outcomes (1)

  • 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

    30 days

Secondary Outcomes (2)

  • SUV

    2 days

  • Number of lesions

    2 days

Study Arms (1)

68Ga-FAPI-LM3

EXPERIMENTAL

Each subject receives a single intravenous injection of 18F-FDG and 68Ga-FAPI-LM3, and undergo PET/CT imaging within the specified time.

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

Interventions

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

68Ga-FAPI-LM3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 0086-361000, China

RECRUITING

Related Publications (1)

  • Zhao L, Pang Y, Fang J, Chen J, Zhou Y, Sun L, Wu H, Guo Z, Lin Q, Chen H. Design, Preclinical Evaluation, and Clinical Translation of 68Ga-FAPI-LM3, a Heterobivalent Molecule for PET Imaging of Nasopharyngeal Carcinoma. J Nucl Med. 2024 Mar 1;65(3):394-401. doi: 10.2967/jnumed.123.266183.

    PMID: 38176714DERIVED

Study Officials

  • Long Sun, PhD

    The First Affiliated Hospital of Xiamen University, Fujian, China

    STUDY DIRECTOR

Central Study Contacts

Long Sun, PhD

CONTACT

86 0592-213707713178352662@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Subjects with malignant diseases (either FAP or SSTR2 positive expression) undergo contemporaneous 68Ga-FAPI-LM3 and 18F-FDG PET/CT for diseases assessment. A part of participants will also undergo additional 68Ga-FAPI-46 PET/CT for comparison.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2023

First Posted

May 24, 2023

Study Start

April 9, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

August 8, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)