Design, Preclinical Evaluation, and Clinical Translation of 68Ga-FAPI-LM3, a Heterobivalent Molecule for PET Imaging of Nasopharyngeal Carcinoma.
Liang Zhao, Yizhen Pang, Jianyang Fang...
https://pubmed.ncbi.nlm.nih.gov/38176714Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID05873777
68Ga-FAPI-LM3 PET/CT Imaging in Patients With FAP/SSTR2 Positive Disease and Compared With 18F-FDG
Led by The First Affiliated Hospital of Xiamen University · Updated on 2025-08-08
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
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 PET/CT scans with the standard 18F-FDG PET/CT scans in patients with SSTR2 positive diseases. Participants receive a single intravenous injection of both 18F-FDG and 68Ga-FAPI-LM3, followed by PET/CT imaging within a specified time frame. Some participants may also have an additional PET/CT 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 PET/CT 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - 1 day
Participants receive a single intravenous injection of 18F-FDG and 68Ga-FAPI-LM3 and undergo PET/CT imaging to assess disease presence.
1 visit (in-person)
Long-term Monitoring
Duration - 30 days
Participants are monitored for diagnostic efficacy and outcomes related to imaging over the following 30 days.
Follow-up assessments as scheduled
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 0086-361000
Actively Recruiting
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Research Team
L
Long Sun, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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