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Recruiting NCT05873777

NCT05873777 68Ga-FAPI-LM3 PET/CT Imaging in Patients With FAP/SSTR2 Positive Disease and Compared With 18F-FDG

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Clinical Trial Summary
NCT ID NCT05873777
Status Recruiting
Phase
Sponsor The First Affiliated Hospital of Xiamen University
Condition SSTR2
Study Type INTERVENTIONAL
Enrollment 30 participants
Start Date 2023-04-09
Primary Completion 2025-12-31

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
18F-FDG PET/CT, 68Ga-FAPI-LM3 PET/CT

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 30 participants in total. It began in 2023-04-09 with a primary completion date of 2025-12-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

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.

Contact & Investigator

Central Contact

Long Sun, PhD

✉ 13178352662@163.com

📞 86 0592-2137077

Principal Investigator

Long Sun, PhD

STUDY DIRECTOR

The First Affiliated Hospital of Xiamen University, Fujian, China

Frequently Asked Questions

Who can join the NCT05873777 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying SSTR2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT05873777 currently recruiting?

Yes, NCT05873777 is actively recruiting participants. Contact the research team at 13178352662@163.com for enrollment information.

Where is the NCT05873777 trial being conducted?

This trial is being conducted at Xiamen, China.

Who is sponsoring the NCT05873777 clinical trial?

NCT05873777 is sponsored by The First Affiliated Hospital of Xiamen University. The principal investigator is Long Sun, PhD at The First Affiliated Hospital of Xiamen University, Fujian, China. The trial plans to enroll 30 participants.

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