What is 68Ga-FAPI-LM3 studying for SSTR2 positive diseases?

68Ga-FAPI-LM3 is being studied as a new imaging agent that targets specific receptors in certain diseases. This trial compares it to the standard 18F-FDG PET/CT scans to see how well it detects lesions. The study is sponsored by The First Affiliated Hospital of Xiamen University and aims to improve diagnostic tools for these diseases.

Who may be eligible for this SSTR2 positive disease clinical trial?

Adults aged 18 years or older with suspected or confirmed malignant disease showing FAP or SSTR2 positive expression may be eligible. Participants must be scheduled for both 18F-FDG and 68Ga-FAPI-LM3 PET/CT scans and able to give informed consent. Please review eligibility criteria for more details.

Is there any cost to participate in this SSTR2 positive disease clinical trial?

Study-related care, including the imaging procedures and all trial visits, is provided at no cost. However, personal travel expenses vary and might not be covered. Participants should plan accordingly for any travel or related costs.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

Healthy Volunteers

ID05873777

68Ga-FAPI-LM3 PETCT Imaging in Patients With FAPSSTR2 Positive Disease and Compared With 18F-FDG

Led by The First Affiliated Hospital of Xiamen University · Updated on 2025-08-08

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating a new imaging agent called 68Ga-FAPI-LM3, which targets two receptors SSTR2 and FAP and may help in diagnosing diseases with SSTR2 positive expression. This study evaluates the safety, how the agent spreads in the body, and the radiation dose it delivers in healthy volunteers. Additionally, it compares the usefulness of 68Ga-FAPI-LM3 PETCT scans with the standard 18F-FDG PETCT scans in patients with SSTR2 positive diseases. Participants receive a single intravenous injection of both 18F-FDG and 68Ga-FAPI-LM3, followed by PETCT imaging within a specified time frame. Some participants may also have an additional PETCT scan using 68Ga-FAPI-46 for comparison. The study measures how well 68Ga-FAPI-LM3 detects lesions compared to 18F-FDG, using maximum standard uptake value SUVmax and counting the number of positive lesions. During the study, participants undergo PETCT scans to assess lesion uptake and distribution of the imaging agents. Researchers record the number of lesions detected and evaluate diagnostic accuracy within 30 days. Safety and radiation dosimetry are monitored in healthy volunteers. The total duration of participation varies, with the primary outcome assessed at 30 days and secondary outcomes at 2 days after imaging.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Adults aged 18 years or older
Patients with suspected, newly diagnosed, or previous malignant disease with FAP or SSTR2 positive expression
Patients scheduled for both 18F-FDG and 68Ga-FAPI-LM3 PET/CT scans
Patients able to provide informed consent and assent according to ethics guidelines

You will not qualify if you...

Patients with non-malignant disease
Pregnant patients
Patients unable or unwilling to provide written informed consent

Research Team

Long Sun, PhD

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