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

Positron-Emission Tomography Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05873777
• Other study ID #: XMFHIIT-2022SL070
• Status: Recruiting
• Phase: N/A
• Start date: April 9, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2023
• Source: The First Affiliated Hospital of Xiamen University
• Contact: Long Sun, PhD
• Phone: 86 0592-2137077
• Email: 13178352662[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• FAP
• Positron-Emission Tomography

Intervention

Diagnostic Test:
• 18F-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

Country	Name	City	State
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	SUV	Standardized uptake value (SUV) of 18F-FDG and 68Ga-FAPI-LM3 PET/CT for each positive lesion of subject.	2 days
Secondary	Number of lesions	The numbers of positive lesions of 18F-FDG and 68Ga-FAPI-LM3 PET/CT were recorded by visual interpretation.	2 days