Clinical trial NCT05873777: 68Ga-FAPI-LM3 PET/CT Imaging in Patients With FAP/SSTR2 Positive Disease and Compared With 18F-FDG
Official title: 68Ga-FAPI-LM3 PET/CT Imaging in Patients With FAP/SSTR2 Positive Disease and Compared With 18F-FDG
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: SSTR2
FAP
Positron-Emission Tomography
Keywords: SSTR2
FAP
Positron-Emission Tomography
Lead sponsor: The First Affiliated Hospital of Xiamen University
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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.

Detailed 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.

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.

Primary outcomes:
measure: Diagnostic efficacy
timeFrame: 30 days
Secondary outcomes:
measure: SUV
timeFrame: 2 days
measure: Number of lesions
timeFrame: 2 days
Other outcomes:
Locations:
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
Study officials:
affiliation: The First Affiliated Hospital of Xiamen University, Fujian, China
name: Long Sun, PhD
role: STUDY_DIRECTOR
References: